Wounds and Injuries
Conditions
Brief summary
The purpose of this study is to examine the effectiveness of the Veraflo with Prontosan vs VAC in wounds that require operative debridement.
Interventions
DEVICEV.A.C.Ulta with Prontosan instillation
NPWT with instillation of a wound cleanser (Prontosan® Wound Irrigation Solution)
DEVICEV.A.C.Ulta without instillation
NPWT only
Sponsors
KCI USA, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The Subject: * has a wound prior to informed consent * will be admitted as an inpatient * is \>= 18 years of age at time of consent * is able to provide his/her own informed consent * is willing and able to return for all scheduled and required study visits * has an open wound \>= 4cm in any plane of measurement excluding tunnels after initial surgical debridement * has a wound that is appropriate for NPWT according to approved indications for use * has not participated in a clinical trial within the past 30 days * has a 30 day wound history available if the wound has been previously treated
Exclusion criteria
The Subject: * is pregnant as determined by a positive serum or urine pregnancy test at the time of screening * has a life expectancy of \< 12 months * is not healthy enough to undergo surgery for any reason * has, in the investigator's opinion, any clinically significant condition that would impair the participant's ability to comply with the study procedures * has, in the opinion of the investigator, a condition that will not allow the subject to tolerate the therapy (e.g. painful conditions such as vasculitis) * has rheumatoid arthritis * has a bleeding disorder or coagulopathy * has a wound that contains antibiotic cement or beads * has an ischemic lower extremity wound as determined by lack of detectable pulses in the extremity or ankle-brachial pressure indices of \< 0.9 with a history of diabetes, or \< 0.6 if the subject is non-diabetic * has a known allergy or hypersensitivity to V.A.C. Therapy dressing components including polyurethane or polyvinyl alcohol (drape and foam), or materials that contain acrylic adhesive (drape adhesive) * has a known allergy or hyper sensitivity to 3M Cavilon No Sting Barrier Film or any of its components including Hexamethyldisiloxane, isooctane, acrylate terpolymer, polyphenylmethysiloxane, copolymer * has a know allergy or hypersensitivity to Prontosan or any of its components including polyhexamethylene biguanide (PHMB), or undecylenamidopropyl betaine * has received NPWT on the study wound within the last 30 days * has a wound that is contraindicated with Prontosan a. presence of hyaline cartilage in the wound * has a wound that is contraindicated with V.A.C. Therapy including: 1. malignancy in the wound 2. untreated osteomyelitis 3. non-enteric or unexplored fistulas 4. necrotic tissue with eschar remaining in the wound after debridement (NOTE: Once necrotic tissue or eschar is removed from the wound bed, subjects may be included) 5. unprotected, exposed blood vessels, anastomotic sites, organs, or nerves in direct contact with foam * use of intervening layers between the wound bed and foam * has a wound that is contraindicated with V.A.C. VeraFlo Therapy including: 1. Thoracic or abdominal cavities 2. Unexplored wounds that may communicate with adjacent body cavities * has a wound that is closed after the initial debridement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Inpatient Operating Room Debridements | until the wound is deemed ready for closure or coverage by the investigator up to 64 days | Debridement in this outcome refers to surgical removal of non viable tissue performed in an operating room |
Secondary
| Measure | Time frame |
|---|---|
| The Difference in Total Bacterial Counts Measured in Colony Forming Units (CFU) as Determined by Quantitative PCR Analysis. | Immediately following initial post debridement to the first dressing change up to 72 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| V.A.C.Ulta With Prontosan Instillation Treatment Arm
V.A.C.Ulta with instillation: NPWT with instillation of a wound cleanser | 93 |
| V.A.C.Ulta Without Instillation Control Arm
V.A.C.Ulta without instillation: NPWT only | 88 |
| Total | 181 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Continuation of therapy | 0 | 1 |
| Overall Study | Interruption to therapy | 3 | 0 |
| Overall Study | Lost to Follow-up | 3 | 5 |
| Overall Study | Missed follow-up assessment | 2 | 1 |
| Overall Study | Osteomyelitis | 0 | 1 |
| Overall Study | Physician Decision | 17 | 12 |
| Overall Study | Sponsor terminated study | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
| Overall Study | Wound recurrence | 0 | 1 |
Baseline characteristics
| Characteristic | V.A.C.Ulta With Prontosan Instillation | Total | V.A.C.Ulta Without Instillation |
|---|---|---|---|
| Age, Continuous | 53.0 years STANDARD_DEVIATION 13.92 | 53.0 years STANDARD_DEVIATION 14.04 | 52.0 years STANDARD_DEVIATION 14.25 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 34 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 73 Participants | 147 Participants | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants | 68 Participants | 34 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 59 Participants | 112 Participants | 53 Participants |
| Region of Enrollment United States | 93 Participants | 181 Participants | 88 Participants |
| Sex: Female, Male Female | 31 Participants | 63 Participants | 32 Participants |
| Sex: Female, Male Male | 62 Participants | 118 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 93 | 1 / 88 |
| other Total, other adverse events | 58 / 93 | 44 / 88 |
| serious Total, serious adverse events | 19 / 93 | 22 / 88 |
Outcome results
Primary
Number of Inpatient Operating Room Debridements
Debridement in this outcome refers to surgical removal of non viable tissue performed in an operating room
Time frame: until the wound is deemed ready for closure or coverage by the investigator up to 64 days
Population: Per-protocol population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| V.A.C.Ulta With Prontosan Instillation | Number of Inpatient Operating Room Debridements | 1 debridement | 52 Participants |
| V.A.C.Ulta With Prontosan Instillation | Number of Inpatient Operating Room Debridements | 3 debridements | 3 Participants |
| V.A.C.Ulta With Prontosan Instillation | Number of Inpatient Operating Room Debridements | 2 debridements | 5 Participants |
| V.A.C.Ulta With Prontosan Instillation | Number of Inpatient Operating Room Debridements | 4 debridements | 2 Participants |
| V.A.C.Ulta With Prontosan Instillation | Number of Inpatient Operating Room Debridements | 0 debridements | 9 Participants |
| V.A.C.Ulta Without Instillation | Number of Inpatient Operating Room Debridements | 4 debridements | 0 Participants |
| V.A.C.Ulta Without Instillation | Number of Inpatient Operating Room Debridements | 0 debridements | 13 Participants |
| V.A.C.Ulta Without Instillation | Number of Inpatient Operating Room Debridements | 1 debridement | 41 Participants |
| V.A.C.Ulta Without Instillation | Number of Inpatient Operating Room Debridements | 2 debridements | 10 Participants |
| V.A.C.Ulta Without Instillation | Number of Inpatient Operating Room Debridements | 3 debridements | 2 Participants |
p-value: 0.677Regression, Logistic
Secondary
The Difference in Total Bacterial Counts Measured in Colony Forming Units (CFU) as Determined by Quantitative PCR Analysis.
Time frame: Immediately following initial post debridement to the first dressing change up to 72 hours
Population: Per-protocol population (some subjects had missing assessments)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| V.A.C.Ulta With Prontosan Instillation | The Difference in Total Bacterial Counts Measured in Colony Forming Units (CFU) as Determined by Quantitative PCR Analysis. | -0.18 Total Bacterial Counts (Log10 CFU) | Standard Deviation 2.15 |
| V.A.C.Ulta Without Instillation | The Difference in Total Bacterial Counts Measured in Colony Forming Units (CFU) as Determined by Quantitative PCR Analysis. | 0.6 Total Bacterial Counts (Log10 CFU) | Standard Deviation 2.01 |
p-value: 0.0202Wilcoxon (Mann-Whitney)
Post Hoc
Number of Inpatient Operating Room Debridements in Surgically Dehisced Wounds
Time frame: until the wound is deemed ready for closure or coverage by the investigator up to 64 days
Population: This only included those patients with wound etiology of Surgically Dehisced Wounds
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| V.A.C.Ulta With Prontosan Instillation | Number of Inpatient Operating Room Debridements in Surgically Dehisced Wounds | 1 debridement | 7 Participants |
| V.A.C.Ulta With Prontosan Instillation | Number of Inpatient Operating Room Debridements in Surgically Dehisced Wounds | 3 debridements | 0 Participants |
| V.A.C.Ulta With Prontosan Instillation | Number of Inpatient Operating Room Debridements in Surgically Dehisced Wounds | 0 debridements | 3 Participants |
| V.A.C.Ulta With Prontosan Instillation | Number of Inpatient Operating Room Debridements in Surgically Dehisced Wounds | 4 debridements | 0 Participants |
| V.A.C.Ulta With Prontosan Instillation | Number of Inpatient Operating Room Debridements in Surgically Dehisced Wounds | 2 debridements | 0 Participants |
| V.A.C.Ulta Without Instillation | Number of Inpatient Operating Room Debridements in Surgically Dehisced Wounds | 4 debridements | 0 Participants |
| V.A.C.Ulta Without Instillation | Number of Inpatient Operating Room Debridements in Surgically Dehisced Wounds | 0 debridements | 1 Participants |
| V.A.C.Ulta Without Instillation | Number of Inpatient Operating Room Debridements in Surgically Dehisced Wounds | 1 debridement | 2 Participants |
| V.A.C.Ulta Without Instillation | Number of Inpatient Operating Room Debridements in Surgically Dehisced Wounds | 2 debridements | 4 Participants |
| V.A.C.Ulta Without Instillation | Number of Inpatient Operating Room Debridements in Surgically Dehisced Wounds | 3 debridements | 2 Participants |
p-value: 0.0142Regression, Logistic