Lower Leg Wound
Conditions
Keywords
debridement, post-debridement, infection, prevention, wound, wound tissue, wound management, WoundWand, wound size reduction, wound bed debridement, WoundWand Debridement Device, chronic wound, delayed healing, cellular senescence, acute wound, diabetic foot ulcer, venous leg ulcers, radiofrequency debridement, necrotic tissue, wound healing, skin
Brief summary
A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention
Detailed description
The primary aim of this pilot study is to investigate differences in bacterial content of the study wound that may impact upon infection rates following debridement with the WoundWand Debridement Device or Standard of Care (SoC) surgical (sharp) debridement. Additionally, the clinical investigation will evaluate reduction in wound size post-debridement and gather Health Economic data relating to wound bed debridement with the WoundWand Debridement Device or SoC.
Interventions
DEVICEWoundWand™ Debridement Device
Group I - Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound
DEVICEStandard of Care sharp debridement
Group II - Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound
Sponsors
Smith & Nephew, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects who meet the following criteria may be included in the clinical investigation, if they present with ALL of the following: 1. Subject is able to understand the evaluation and willing to consent and comply with all post-debridement visits and procedures 2. Age 18 years and older. Subjects may be of either sex and of any race or skin type 3. Subjects fulfilling any one or all of the following criteria: 1. chronic wound(s) below the level of the knee, defined by delayed healing or cellular senescence 2. acute wound(s) as a result of a surgical procedure, laceration, abrasion or trauma 3. diabetic foot ulcer(s) 4. subjects with venous leg ulcers below the knee on the leg or foot with one or more documented failure of maximal medical therapy for their study wound \>30 days such as compression bandages (low elasticity, elastic, multilayered, elastic and non elastic compression) 4. Subjects with the following lab results within 30 days of treatment: 1. serum albumin level \>20g/L 2. clinically non significant results of liver function test (LFTs), serum glucose and complete blood count (CBC) with differential 5. Subjects with a Braden Score ≥13-14 (Moderate Risk) 6. Subjects with adequate arterial blood flow \[Ankle-Brachial Index (ABI) \>0.75\]
Exclusion criteria
Subjects will be excluded from the clinical investigation, if they present with ANY of the following: 1. Subjects that have tunneling wounds 2. Subject presents with an active infection in the study wound, as defined by purulence and: 1. Fever and leukocytosis OR any TWO of the following: 2. Malodor, pain or tenderness, warmth, erythema, induration, swelling, lymphangitis 3. Infected bone diagnosed by imaging modality (e.g., Magnetic Resonance Imaging (MRI) and/or radiographic images) 4. Subjects whose study wound does not require debridement 5. Cardiac pacemaker or other electronic implant(s) 6. Subjects with irradiate, burn or ischaemic wounds or history of keloids 7. Subjects with vasculitis, non-reconstructive peripheral vascular disease, pyoderma gangrenosum, renal failure or lymphoedema 8. Subjects with uncontrolled bleeding disorder (PT/PTT) and coagulopathy (including those with hemophilia) 9. Subjects taking treatment with any of the following: 1. Systemic corticosteroids 2. Immunosuppressive agent(s) 3. Chemotherapy or Radiation therapy 10. Subjects deemed to require biologic dressing/ skin substitute 11. Terminally ill subjects 12. Subjects that have an immunodeficiency disorder that interferes with wound healing, including Acquired Immunodeficiency Syndrome (AIDS) or know to be infected with Human Immunodeficiency Virus (HIV) 13. Subjects that have chronic skin conditions such as psoriasis, etc. 14. Subjects that reside in a nursing home 15. Subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.) to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant 16. Subject is pregnant and/or intending to become pregnant during this clinical investigation period 17. Subject has documented evidence of a history (e.g. liver testing) of drug/alcohol abuse within the 12 months prior to enrollment for clinical investigation entry 18. Subject is excluded if they have received an investigational therapy or approved therapy for investigational use within 30 days of surgery 19. Subject is excluded if planning to participate in another research study during the follow-up phase of this study or 84 days after study completion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacterial Diversity and Number of Bacteria Present in the Wound | Day 1 (immediately pre- and post-debridement) and 4 weeks post-debridement | Primary endpoint was to determine bacterial diversity and number of bacteria present in the study wound at 4 weeks post- debridement using either WoundWand Debridement Device or Standard of Care. Punch biopsies were performed per standard practice to quantify the type and amount of bacteria present in wounds debrided with either Standard of Care Sharp Debridement or WoundWand Debridement Device. Debridement of contaminated tissue is essential to prevent wound infection, promote healing, and provide a neat wound edge for the prevention of scaring. A 3-4 mm punch biopsy for quantitative tissue culture (i.e. bacterial content) will be collected from the study wound site immediately pre- and post-debridement and at Week 4. The punch biopsy will be performed per standard practice and if required, utilizing the appropriate analgesia \[e.g. general, local (e.g. 1% lidocaine with epinephrine)\]. Quantitative tissue culture will be completed according to the laboratory's standard procedures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Photograph Area Measurements to Determine Reduction in Wound Size | Visit 2 through Visit 8 (12 weeks) | a) Reduction in wound size for up to 12 weeks post-debridement Photographs of the wound site were taken to determine the reduction in wound size and to assess healing progression of the study wound. Standardization of images was ensured by the Eykona® Wound Measurement System that uses small sterile 'targets' placed on the study wound to set the focus and position of the camera thus eliminating inconsistency between images acquisition time points. The photographs are stored on a USB (Universal Serial Bus) flash drive which will be archived with the study files. |
| Wound Status Using Bates-Jensen Wound Assessment - Total Score | Screening through Visit 8 (12 weeks) | The Bates-Jensen Wound Assessment Tool is a 13-item questionnaire (size, depth, edges, undermining, necrotic tissue type, exudate type, exudate amount, skin color surrounding wound, peripheral tissue edema, peripheral tissue induration, granulation tissue, epithelialization) used to assess wound status. Total score is determined by adding together the sub-scores from each of the 13 items, with a higher score indicating a more severe wound status. Each of the 13 item scores ranged from 1 to 5 possible points. Minimum score of 13 indicated the best outcome, maximum score of 65 indicated the worst outcome. |
| Braden Scale for Predicting Pressure Sore Risk - Total Score | Screening through Visit 8 (12 weeks) | The Braden Scale, performed by the Investigator (or designee), is a 6-item questionnaire (sensory perception, moisture, activity, mobility, nutrition, and friction &shear) used to assess the subject's level of risk for development of pressure ulcers. Total score is determined by adding together the sub-scores from each of the 6 items, with a lower score indicating a higher risk for developing pressure ulcers. Braden Scale thresholds: 19-23 = not at risk 15-18 = preventative interventions 13-14 = moderate risk 10-12 = high risk 6-9 = very high risk Sub-score ranges: Sensory perception: 1 - 4 Moisture: 1 - 4 Activity: 1 - 4 Mobility: 1 - 4 Nutrition: 1 - 4 Friction & Shear: 1 - 3 Total score minimum of 6 indicated a very high risk outcome, maximum score of 23 indicated the subject not at risk. |
Countries
France, United Kingdom
Participant flow
Recruitment details
Sixty (60) subjects were to be randomized in a 1:1 ratio. A total of 11 subjects were enrolled at 1 investigative site by 2 investigators.
Pre-assignment details
Overall, 9 subjects received treatment for a total of 9 wounds treated. Two of the enrolled subjects, discontinued prior to treatment.
Participants by arm
| Arm | Count |
|---|---|
| WoundWand™ Debridement Device WoundWand™ Debridement Device: Group I - Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound. ArthroCare developed COBLATION® technology, which uses a controlled, non-heat drive process (i.e., radiofrequency energy) to gently and precisely dissolve soft tissue, thereby minimizing damage to healthy tissue. ArthroCare adapted this technology for use in wound debridement via the WoundWand Debridement Device. | 5 |
| Standard of Care Sharp Debridement Standard of Care sharp debridement: Group II - Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound. Surgical or sharp debridement is one of the methods commonly used to remove necrotic tissue from non-healing and difficult-to-heal chronic wounds. Surgical debridement requires sterile instruments and a qualified clinician in addition to general or local anesthesia. | 4 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 2 | 1 |
Baseline characteristics
| Characteristic | WoundWand™ Debridement Device | Standard of Care Sharp Debridement | Total |
|---|---|---|---|
| Age, Continuous | 66.4 years STANDARD_DEVIATION 8.6 | 68.8 years STANDARD_DEVIATION 13.6 | 67.8 years STANDARD_DEVIATION 10.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 4 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Etiology of Study Wound Abrasion | 0 Participants | 0 Participants | 0 Participants |
| Etiology of Study Wound Infection | 1 Participants | 0 Participants | 1 Participants |
| Etiology of Study Wound Infection, Trauma and Neuropathy | 0 Participants | 1 Participants | 1 Participants |
| Etiology of Study Wound Laceration | 0 Participants | 0 Participants | 0 Participants |
| Etiology of Study Wound Neuropathy | 0 Participants | 0 Participants | 0 Participants |
| Etiology of Study Wound Other | 0 Participants | 0 Participants | 0 Participants |
| Etiology of Study Wound Pressure | 2 Participants | 2 Participants | 4 Participants |
| Etiology of Study Wound Pressure and Neuropathy | 0 Participants | 1 Participants | 1 Participants |
| Etiology of Study Wound Surgical Procedure | 0 Participants | 0 Participants | 0 Participants |
| Etiology of Study Wound Surgical Procedure and Underlying Condition | 1 Participants | 0 Participants | 1 Participants |
| Etiology of Study Wound Trauma | 0 Participants | 0 Participants | 0 Participants |
| Etiology of Study Wound Underlying Condition | 0 Participants | 0 Participants | 0 Participants |
| Etiology of Study Wound Vascular Insufficiency | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 4 Participants | 8 Participants |
| Region of Enrollment United Kingdom | 5 participants | 4 participants | 9 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
| Type of Wound Acute | 0 Participants | 0 Participants | 0 Participants |
| Type of Wound Chronic | 0 Participants | 1 Participants | 1 Participants |
| Type of Wound Chronic and Diabetic Foot Ulcer | 0 Participants | 2 Participants | 2 Participants |
| Type of Wound Diabetic Foot Ulcer | 5 Participants | 1 Participants | 6 Participants |
| Type of Wound Venous Leg Ulcer | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 4 / 5 | 2 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 |
Outcome results
Primary
Bacterial Diversity and Number of Bacteria Present in the Wound
Primary endpoint was to determine bacterial diversity and number of bacteria present in the study wound at 4 weeks post- debridement using either WoundWand Debridement Device or Standard of Care. Punch biopsies were performed per standard practice to quantify the type and amount of bacteria present in wounds debrided with either Standard of Care Sharp Debridement or WoundWand Debridement Device. Debridement of contaminated tissue is essential to prevent wound infection, promote healing, and provide a neat wound edge for the prevention of scaring. A 3-4 mm punch biopsy for quantitative tissue culture (i.e. bacterial content) will be collected from the study wound site immediately pre- and post-debridement and at Week 4. The punch biopsy will be performed per standard practice and if required, utilizing the appropriate analgesia \[e.g. general, local (e.g. 1% lidocaine with epinephrine)\]. Quantitative tissue culture will be completed according to the laboratory's standard procedures
Time frame: Day 1 (immediately pre- and post-debridement) and 4 weeks post-debridement
Population: All treated subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-010 - Total Pseudomonads/Week 4 | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-001 - Total Strep/Pre | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-001 - Total Strep/Post | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-001 - Total Strep/Week 4 | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-003 - Total Staph/Week 4 | 6.70 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-009 - Total Gram Negative Anaerobes/Pre | 5.82 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-009 - Total Gram - Anaerobes/Post | 3.96 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-003 - Total Strep/Pre | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-003 - Total Strep/Post | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-003 - Total Strep/Week 4 | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-009 - Total Gram - Anaerobes/Week 4 | 3.59 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-007 - Total S. aureus/Pre | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-007 - Total S. aureus/Post | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-007 - Total S. aureus/Week 4 | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-010 - Total Gram Negative Anaerobes/Pre | 5.73 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-010 - Total Gram - Anaerobes/Post | 6.07 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-007 - Total Strep/Pre | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-007 - Total Strep/Post | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-007 - Total Strep/Week 4 | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-010 - Total Gram - Anaerobes/Week 4 | 8.62 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-009 - Total S. aureus/Pre | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-009 - Total S. aureus/Post | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-009 - Total Strep/Pre | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-009 - Total Strep/Post | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-009 - Total Strep/Week 4 | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-010 - Total Strep/Pre | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-010 - Total Strep/Post | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-010 - Total Strep/Week 4 | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-001 - Total Aerobes/Pre | 7.74 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-001 - Total Aerobes/Post | 7.25 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-001 - Total Aerobes/Week 4 | 6.29 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-009 - Total S. aureus/Week 4 | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-010 - Total S. aureus/Pre | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-010 - Total S. aureus/Post | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-003 - Total Aerobes/Pre | 9.14 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-003 - Total Aerobes/Post | 4.38 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-003 - Total Aerobes/Week 4 | 6.67 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-010 - Total S. aureus/Week 4 | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-001 - Total Coliforms/Pre | 6.83 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-001 - Total Coliforms/Post | 3.53 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-001 - Total Coliforms/Week 4 | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-007 - Total Staphylococci/Pre | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-007 - Total Staph/Post | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-007 - Total Aerobes/Pre | 7.42 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-007 - Total Aerobes/Post | 5.12 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-007 - Total Aerobes/Week 4 | 8.08 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-007 - Total Staph/Week 4 | 3.93 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-003 - Total Coliforms/Pre | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-003 - Total Coliforms/Post | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-009 - Total Aerobes/Pre | 6.90 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-009 - Total Aerobes/Post | 4.41 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-009 - Total Aerobes/Week 4 | 8.56 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-010 - Total Aerobes/Pre | 7.30 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-010 - Total Aerobes/Post | 7.24 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-001 - Total Gram Positive Anaerobes/Pre | 7.66 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-001 - Total Gram + Anaerobes/Post | 5.25 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-001 - Total Gram + Anaerobes/Week 4 | 5.66 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-003 - Total Coliforms/Week 4 | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-001 - Total Staphylococci/Pre | 7.11 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-001 - Total Staph/Post | 4.56 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-003 - Total Gram Positive Anaerobes/Pre | 8.66 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-003 - Total Gram + Anaerobes/Post | 3.36 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-003 - Total Gram + Anaerobes/Week 4 | 7.60 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-001 - Total Staph/Week 4 | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-009 - Total Staphylococci/Pre | 6.97 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-009 - Total Staph/Post | 4.64 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-007 - Total Coliforms/Pre | 7.33 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-007 - Total Coliforms/Post | 4.99 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-007 - Total Coliforms/Week 4 | 4.57 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-007 - Total Gram Positive Anaerobes/Pre | 5.28 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-007 - Total Gram + Anaerobes/Post | 3.29 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-007 - Total Gram + Anaerobes/Week 4 | 3.92 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-009 - Total Staph/Week 4 | 8.47 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-010 - Total Staphylococci/Pre | 7.05 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-010 - Total Staph/Post | 6.87 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-009 - Total Gram Positive Anaerobes/Pre | 4.28 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-009 - Total Gram + Anaerobes/Post | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-009 - Total Gram + Anaerobes/Week 4 | 8.70 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-010 - Total Gram Positive Anaerobes/Pre | 4.30 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-010 - Total Gram + Anaerobes/Post | 3.15 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-010 - Total Gram + Anaerobes/Week 4 | 7.66 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-001 - Total Gram Negative Anaerobes/Pre | 6.98 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-001 - Total Gram - Anaerobes/Post | 3.21 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-001 - Total Gram - Anaerobes/Week 4 | 4.80 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-009 - Total Coliforms/Pre | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-009 - Total Coliforms/Post | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-009 - Total Coliforms/Week 4 | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-003 - Total Gram Negative Anaerobes/Pre | 8.90 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-003 - Total Gram - Anaerobes/Post | 3.70 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-003 - Total Gram - Anaerobes/Week 4 | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-010 - Total Coliforms/Pre | 7.14 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-010 - Total Coliforms/Post | 6.89 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-010 - Total Coliforms/Week 4 | 8.24 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-001 - Total Pseudomonads/Pre | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-001 - Total Pseudomonads/Post | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-010 - Total Aerobes/Week 4 | 8.79 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-001 - Total Pseudomonads/Week 4 | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-010 - Total Staph/Week 4 | 8.15 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-001 - Total S. aureus/Pre | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-001 - Total S. aureus/Post | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-003 - Total Pseudomonads/Pre | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-003 - Total Pseudomonads/Post | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-003 - Total Pseudomonads/Week 4 | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-001 - Total S. aureus/Week 4 | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-007 - Total Gram Negative Anaerobes/Pre | 7.54 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-007 - Total Gram - Anaerobes/Post | 5.13 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-007 - Total Gram - Anaerobes/Week 4 | 7.89 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-003 - Total Staphylococci/Pre | 8.75 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-003 - Total S. aureus/Pre | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-007 - Total Pseudomonads/Pre | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-007 - Total Pseudomonads/Post | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-007 - Total Pseudomonads/Week 4 | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-003 - Total S. aureus/Post | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-003 - Total S. aureus/Week 4 | 6.58 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-003 - Total Staph/Post | 4.38 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-009 - Total Pseudomonads/Pre | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-009 - Total Pseudomonads/Post | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-009 - Total Pseudomonads/Week 4 | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-010 - Total Pseudomonads/Pre | 0.00 Log^10 CFU/g |
| WoundWand™ Debridement Device | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-010 - Total Pseudomonads/Post | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-005 - Total Gram - Anaerobes/Week 4 | 6.30 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-004 - Total Coliforms/Post | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-008 - Total Gram Negative Anaerobes/Pre | 3.31 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-008 - Total Gram - Anaerobes/Post | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-008 - Total Gram - Anaerobes/Week 4 | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-002 - Total Staphylococci/Pre | 6.39 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-002 - Total Staph/Post | 5.92 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-002 - Total Staph/Week 4 | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-004 - Total Staphylococci/Pre | 5.15 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-004 - Total Staph/Post | 3.25 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-004 - Total Staph/Week 4 | 7.55 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-005 - Total Staphylococci/Pre | 8.37 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-005 - Total Staph/Post | 6.67 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-005 - Total Staph/Week 4 | 6.69 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-008 - Total Staphylococci/Pre | 7.24 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-008 - Total Staph/Post | 5.93 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-008 - Total Staph/Week 4 | 3.43 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-002 - Total S. aureus/Pre | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-002 - Total S. aureus/Post | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-002 - Total S. aureus/Week 4 | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-004 - Total S. aureus/Week 4 | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-004 - Total S. aureus/Pre | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-004 - Total S. aureus/Post | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-005 - Total S. aureus/Pre | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-005 - Total S. aureus/Post | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-005 - Total S. aureus/Week 4 | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-008 - Total S. aureus/Pre | 6.89 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-008 - Total S. aureus/Post | 5.49 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-008 - Total S. aureus/Week 4 | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-002 - Total Coliforms/Pre | 6.84 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-002 - Total Coliforms/Post | 5.58 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-002 - Total Coliforms/Week 4 | 4.68 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-004 - Total Coliforms/Pre | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-004 - Total Coliforms/Week 4 | 4.23 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-005 - Total Coliforms/Pre | 6.50 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-005 - Total Coliforms/Post | 5.56 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-005 - Total Coliforms/Week 4 | 6.26 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-008 - Total Coliforms/Pre | 7.75 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-008 - Total Coliforms/Post | 7.37 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-008 - Total Coliforms/Week 4 | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-002 - Total Pseudomonads/Pre | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-002 - Total Pseudomonads/Post | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-002 - Total Pseudomonads/Week 4 | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-004 - Total Pseudomonads/Pre | 5.89 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-004 - Total Pseudomonads/Post | 4.87 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-004 - Total Pseudomonads/Week 4 | 4.43 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-005 - Total Pseudomonads/Pre | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-005 - Total Pseudomonads/Post | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-005 - Total Pseudomonads/Week 4 | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-008 - Total Pseudomonads/Pre | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-008 - Total Pseudomonads/Post | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-008 - Total Pseudomonads/Week 4 | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-002 - Total Strep/Pre | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-002 - Total Strep/Post | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-002 - Total Strep/Week 4 | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-004 - Total Strep/Pre | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-004 - Total Strep/Post | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-004 - Total Strep/Week 4 | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-005 - Total Strep/Pre | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-005 - Total Strep/Post | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-005 - Total Strep/Week 4 | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-008 - Total Strep/Pre | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-008 - Total Strep/Post | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-008 - Total Strep/Week 4 | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-002 - Total Aerobes/Pre | 8.37 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-002 - Total Aerobes/Post | 7.05 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-002 - Total Aerobes/Week 4 | 5.31 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-004 - Total Aerobes/Pre | 5.99 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-004 - Total Aerobes/Post | 4.91 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-004 - Total Aerobes/Week 4 | 7.70 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-005 - Total Aerobes/Pre | 8.46 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-005 - Total Aerobes/Post | 6.75 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-005 - Total Aerobes/Week 4 | 6.38 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-008 - Total Aerobes/Pre | 7.84 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-008 - Total Aerobes/Post | 7.41 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-008 - Total Aerobes/Week 4 | 4.09 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-002 - Total Gram Positive Anaerobes/Pre | 8.50 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-002 - Total Gram + Anaerobes/Post | 7.05 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-002 - Total Gram + Anaerobes/Week 4 | 3.83 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-004 - Total Gram Positive Anaerobes/Pre | 5.02 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-004 - Total Gram + Anaerobes/Post | 3.80 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-004 - Total Gram + Anaerobes/Week 4 | 6.43 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-005 - Total Gram Positive Anaerobes/Pre | 7.42 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-005 - Total Gram + Anaerobes/Post | 5.58 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-005 - Total Gram + Anaerobes/Week 4 | 4.56 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-008 - Total Gram Positive Anaerobes/Pre | 7.61 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-008 - Total Gram + Anaerobes/Post | 7.41 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-008 - Total Gram + Anaerobes/Week 4 | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-002 - Total Gram Negative Anaerobes/Pre | 7.30 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-002 - Total Gram - Anaerobes/Post | 5.57 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-002 - Total Gram - Anaerobes/Week 4 | 4.75 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-004 - Total Gram Negative Anaerobes/Pre | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-004 - Total Gram - Anaerobes/Post | 0.00 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-004 - Total Gram - Anaerobes/Week 4 | 5.88 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | Subject 02-005 - Total Gram Negative Anaerobes/Pre | 6.54 Log^10 CFU/g |
| Standard of Care Sharp Debridement | Bacterial Diversity and Number of Bacteria Present in the Wound | 02-005 - Total Gram - Anaerobes/Post | 5.59 Log^10 CFU/g |
Secondary
Braden Scale for Predicting Pressure Sore Risk - Total Score
The Braden Scale, performed by the Investigator (or designee), is a 6-item questionnaire (sensory perception, moisture, activity, mobility, nutrition, and friction &shear) used to assess the subject's level of risk for development of pressure ulcers. Total score is determined by adding together the sub-scores from each of the 6 items, with a lower score indicating a higher risk for developing pressure ulcers. Braden Scale thresholds: 19-23 = not at risk 15-18 = preventative interventions 13-14 = moderate risk 10-12 = high risk 6-9 = very high risk Sub-score ranges: Sensory perception: 1 - 4 Moisture: 1 - 4 Activity: 1 - 4 Mobility: 1 - 4 Nutrition: 1 - 4 Friction & Shear: 1 - 3 Total score minimum of 6 indicated a very high risk outcome, maximum score of 23 indicated the subject not at risk.
Time frame: Screening through Visit 8 (12 weeks)
Population: All available subjects at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WoundWand™ Debridement Device | Braden Scale for Predicting Pressure Sore Risk - Total Score | Visit 4/Week 2 | 17.8 total score on a scale | Standard Deviation 3.1 |
| WoundWand™ Debridement Device | Braden Scale for Predicting Pressure Sore Risk - Total Score | Visit 6/Week 4 | 17.8 total score on a scale | Standard Deviation 2.8 |
| WoundWand™ Debridement Device | Braden Scale for Predicting Pressure Sore Risk - Total Score | Visit 3/Week 1 | 17.6 total score on a scale | Standard Deviation 2.9 |
| WoundWand™ Debridement Device | Braden Scale for Predicting Pressure Sore Risk - Total Score | Visit 7/Week 6 | 18.0 total score on a scale | Standard Deviation 1.7 |
| WoundWand™ Debridement Device | Braden Scale for Predicting Pressure Sore Risk - Total Score | Visit 5/Week 3 | 17.8 total score on a scale | Standard Deviation 3.6 |
| WoundWand™ Debridement Device | Braden Scale for Predicting Pressure Sore Risk - Total Score | Visit 8/Week 12 | 19.3 total score on a scale | Standard Deviation 3.8 |
| WoundWand™ Debridement Device | Braden Scale for Predicting Pressure Sore Risk - Total Score | Visit 1/Screening | 17.8 total score on a scale | Standard Deviation 2.6 |
| Standard of Care Sharp Debridement | Braden Scale for Predicting Pressure Sore Risk - Total Score | Visit 8/Week 12 | 20.0 total score on a scale | Standard Deviation 4.4 |
| Standard of Care Sharp Debridement | Braden Scale for Predicting Pressure Sore Risk - Total Score | Visit 1/Screening | 18.5 total score on a scale | Standard Deviation 3.1 |
| Standard of Care Sharp Debridement | Braden Scale for Predicting Pressure Sore Risk - Total Score | Visit 3/Week 1 | 18.0 total score on a scale | Standard Deviation 2.2 |
| Standard of Care Sharp Debridement | Braden Scale for Predicting Pressure Sore Risk - Total Score | Visit 4/Week 2 | 18.0 total score on a scale | Standard Deviation 2.2 |
| Standard of Care Sharp Debridement | Braden Scale for Predicting Pressure Sore Risk - Total Score | Visit 5/Week 3 | 18.3 total score on a scale | Standard Deviation 2.9 |
| Standard of Care Sharp Debridement | Braden Scale for Predicting Pressure Sore Risk - Total Score | Visit 6/Week 4 | 18.5 total score on a scale | Standard Deviation 3.3 |
| Standard of Care Sharp Debridement | Braden Scale for Predicting Pressure Sore Risk - Total Score | Visit 7/Week 6 | 20.0 total score on a scale | Standard Deviation 4.4 |
Secondary
Photograph Area Measurements to Determine Reduction in Wound Size
a) Reduction in wound size for up to 12 weeks post-debridement Photographs of the wound site were taken to determine the reduction in wound size and to assess healing progression of the study wound. Standardization of images was ensured by the Eykona® Wound Measurement System that uses small sterile 'targets' placed on the study wound to set the focus and position of the camera thus eliminating inconsistency between images acquisition time points. The photographs are stored on a USB (Universal Serial Bus) flash drive which will be archived with the study files.
Time frame: Visit 2 through Visit 8 (12 weeks)
Population: All treated subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-003 Visit 7/Week 6 | 3.99 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | Subject 02-007 Visit 2/Pre Debridement | 23.56 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-007 Visit 2/Pre Debridement | 25.87 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-007 Visit 2/Post Debridement | NA cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-007 Visit 3/Week 1 | 26.91 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-007 Visit 4/Week 2 | 23.02 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-007 Visit 5/Week 3 | 24.89 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-007 Visit 6/Week 4 | 28.04 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-007 Visit 7/Week 6 | NA cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-007 Visit 8/Week 12 | NA cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-003 Visit 8/Week 12 | 1.43 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | Subject 02-001 Visit 2/Pre Debridement | NA cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-001 Visit 2/Post Debridement | 80.24 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-001 Visit 3/Week 1 | 57.24 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-001 Visit 4/Week 2 | 58.36 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-001 Visit 5/Week 3 | 50.15 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-001 Visit 6/Week 4 | 52.12 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-001 Visit 7/Week 6 | 35.61 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-001 Visit 7/Week 6 measurement 2 | 29.70 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-001 Visit 8/Week 12 | 17.84 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | Subject 02-003 Visit 2/Pre Debridement | 6.80 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-003 Visit 2/Post Debridement | 9.34 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | Subject 02-009 Visit 2/Pre Debridement | 50.49 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-009 Visit 2/Post Debridement | 35.05 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-009 Visit 3/Week 1 | 67.80 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-009 Visit 4/Week 2 | 26.84 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-009 Visit 5/Week 3 | 23.02 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-009 Visit 6/Week 4 | 38.27 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-009 Visit 7/Week 6 | NA cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-009 Visit 8/Week 12 | NA cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | Subject 02-010 Visit 2/Pre Debridement | 9.03 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-010 Visit 2/Post Debridement | 9.39 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-010 Visit 3/Week 1 | 24.15 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-010 Visit 3/Week 1 measurement 2 | 6.55 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-010 Visit 4/Week 2 | 6.99 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-010 Visit 5/Week 3 | 5.08 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-010 Visit 6/Week 4 | 15.42 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-010 Visit 7/Week 6 | NA cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-010 Visit 8/Week 12 | NA cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-003 Visit 3/Week 1 | 6.25 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-003 Visit 4/Week 2 | 6.29 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-003 Visit 4/Week 2 measurement 2 | 9.18 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-003 Visit 5/Week 3 | 2.88 cm^2 |
| WoundWand™ Debridement Device | Photograph Area Measurements to Determine Reduction in Wound Size | 02-003 Visit 6/Week 4 | 3.05 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-005 Visit 5/Week 3 | 22.16 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | Subject 02-002 Visit 2/Pre Debridement | 41.80 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-002 Visit 2/Post Debridement | NA cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-002 Visit 3/Week 1 | 53.59 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-002 Visit 4/Week 2 | 30.03 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-002 Visit 5/Week 3 | 40.08 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-002 Visit 6/Week 4 | 31.73 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-002 Visit 7/Week 6 | 37.43 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-002 Visit 7/Week 6 measurement 2 | 33.99 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-002 Visit 8/Week 12 | 22.79 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | Subject 02-004 Visit 2/Pre Debridement | 2.37 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-004 Visit 2/Post Debridement | 0.59 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-004 Visit 3/Week 1 | 1.25 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-004 Visit 3/Week 1 measurement 2 | 1.35 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-004 Visit 4/Week 2 | 1.02 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-004 Visit 5/Week 3 | 1.84 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-004 Visit 6/Week 4 | 2.41 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-004 Visit 8/Week 12 | 0.33 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | Subject 02-005 Visit 2/Pre Debridement | 16.20 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-005 Visit 2/Post Debridement | 28.74 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-005 Visit 3/Week 1 | 19.53 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-005 Visit 3/Week 1 measurement 2 | 19.98 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-005 Visit 4/Week 2 | 23.67 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-004 Visit 7/Week 6 | 0.42 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-005 Visit 6/Week 4 | 21.40 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-005 Visit 7/Week 6 | 34.06 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-005 Visit 8/Week 12 | 26.56 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | Subject 02-008 Visit 2/Pre Debridement | 29.53 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-008 Visit 2/Post Debridement | 86.16 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-008 Visit 3/Week 1 | 50.26 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-008 Visit 3/Week 1 measurement 2 | 85.47 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-008 Visit 4/Week 2 | 30.13 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-008 Visit 4/Week 2 measurement 2 | 72.20 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-008 Visit 5/Week 3 | 19.65 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-008 Visit 5/Week 3 measurement 2 | 33.32 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-008 Visit 6/Week 4 | 93.46 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-008 Visit 6/Week 4 measurement 2 | 24.75 cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-008 Visit 7/Week 6 | NA cm^2 |
| Standard of Care Sharp Debridement | Photograph Area Measurements to Determine Reduction in Wound Size | 02-008 Visit 8/Week 12 | NA cm^2 |
Secondary
Wound Status Using Bates-Jensen Wound Assessment - Total Score
The Bates-Jensen Wound Assessment Tool is a 13-item questionnaire (size, depth, edges, undermining, necrotic tissue type, exudate type, exudate amount, skin color surrounding wound, peripheral tissue edema, peripheral tissue induration, granulation tissue, epithelialization) used to assess wound status. Total score is determined by adding together the sub-scores from each of the 13 items, with a higher score indicating a more severe wound status. Each of the 13 item scores ranged from 1 to 5 possible points. Minimum score of 13 indicated the best outcome, maximum score of 65 indicated the worst outcome.
Time frame: Screening through Visit 8 (12 weeks)
Population: All subjects seen and assessed at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WoundWand™ Debridement Device | Wound Status Using Bates-Jensen Wound Assessment - Total Score | Visit 1/Screening | 33.2 total score on a scale | Standard Deviation 3.1 |
| WoundWand™ Debridement Device | Wound Status Using Bates-Jensen Wound Assessment - Total Score | Visit 2/Debridement | 35.2 total score on a scale | Standard Deviation 5.8 |
| WoundWand™ Debridement Device | Wound Status Using Bates-Jensen Wound Assessment - Total Score | Visit 3/Week 1 | 31.0 total score on a scale | Standard Deviation 6.4 |
| WoundWand™ Debridement Device | Wound Status Using Bates-Jensen Wound Assessment - Total Score | Visit 4/Week 2 | 27.8 total score on a scale | Standard Deviation 2.9 |
| WoundWand™ Debridement Device | Wound Status Using Bates-Jensen Wound Assessment - Total Score | Visit 5/Week 3 | 25.2 total score on a scale | Standard Deviation 3.1 |
| WoundWand™ Debridement Device | Wound Status Using Bates-Jensen Wound Assessment - Total Score | Visit 6/Week 4 | 25.5 total score on a scale | Standard Deviation 5.7 |
| WoundWand™ Debridement Device | Wound Status Using Bates-Jensen Wound Assessment - Total Score | Visit 7/Week 6 | 18.7 total score on a scale | Standard Deviation 0.6 |
| WoundWand™ Debridement Device | Wound Status Using Bates-Jensen Wound Assessment - Total Score | Visit 8/Week 12 | 16.0 total score on a scale | Standard Deviation 1.7 |
| Standard of Care Sharp Debridement | Wound Status Using Bates-Jensen Wound Assessment - Total Score | Visit 8/Week 12 | 31.0 total score on a scale | Standard Deviation 20.9 |
| Standard of Care Sharp Debridement | Wound Status Using Bates-Jensen Wound Assessment - Total Score | Visit 1/Screening | 33.8 total score on a scale | Standard Deviation 4.8 |
| Standard of Care Sharp Debridement | Wound Status Using Bates-Jensen Wound Assessment - Total Score | Visit 5/Week 3 | 33.3 total score on a scale | Standard Deviation 6.1 |
| Standard of Care Sharp Debridement | Wound Status Using Bates-Jensen Wound Assessment - Total Score | Visit 2/Debridement | 33.3 total score on a scale | Standard Deviation 5.6 |
| Standard of Care Sharp Debridement | Wound Status Using Bates-Jensen Wound Assessment - Total Score | Visit 7/Week 6 | 31.0 total score on a scale | Standard Deviation 10.1 |
| Standard of Care Sharp Debridement | Wound Status Using Bates-Jensen Wound Assessment - Total Score | Visit 3/Week 1 | 34.0 total score on a scale | Standard Deviation 5 |
| Standard of Care Sharp Debridement | Wound Status Using Bates-Jensen Wound Assessment - Total Score | Visit 6/Week 4 | 32.3 total score on a scale | Standard Deviation 7.6 |
| Standard of Care Sharp Debridement | Wound Status Using Bates-Jensen Wound Assessment - Total Score | Visit 4/Week 2 | 33.3 total score on a scale | Standard Deviation 5.4 |