Granulation Tissue, Wound Healing, Wounds and Injuries
Conditions
Brief summary
Evaluation of wound bed surface area containing clean, healthy viable tissue in full-thickness wounds.
Detailed description
This study evaluates changes in wound bed surface area of clean, healthy viable tissue in subjects with full-thickness wounds using negative pressure wound therapy with instillation of saline solution versus a collagenase ointment.
Interventions
DEVICENegative Pressure Therapy w/ instillation and dwell (NPWTi-d)
Negative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days.
BIOLOGICALCollagenase Ointment
Collagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days.
Sponsors
3M
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: 1. is anticipated to be hospitalized for the duration of treatment (minimum of 6 days). 2. is ≥ 18 years of age. 3. or their legally authorized representative is able to provide informed consent. 4. has been diagnosed with a wound (eg, chronic, acute, traumatic, or dehisced wounds) and/or ulcer (ie, full- thickness wounds) that meets the following criteria: 1. total surface area measuring ≥ 16 cm2, including a minimum width of 2 cm (before removal of eschar at the bedside and excluding undermining). 2. \< 20 cm across (edge-to-edge) at any point perpendicular to the wound edges. 5. has, in the opinion of the investigator, no more than 2/3 of the wound bed surface area considered to be clean, healthy, and viable. If eschar is present at baseline, it must be removed by bedside debridement prior to assessing the percentage of clean, healthy, and viable wound bed. 6. has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy) and is willing to take precautionary measures to prevent pregnancy during the duration of the study (up to 9 days).
Exclusion criteria
The Subject: 1. has been diagnosed with malignancy in the wound. 2. has untreated osteomyelitis. 3. has an untreated systemic infection. 4. has active cellulitis in the periwound area. 5. has a known allergy or hypersensitivity to study materials: collagenase ointment, dressing(s), and/or dressing components such as acrylic adhesives or polyurethane. 6. has, in the opinion of the investigator, a clinically significant condition that would impair the Subject's ability to comply with the study procedures. 7. has had radiation directly to the wound area. 8. has been diagnosed with a major vascular deficit limiting arterial inflow to the wound region, as determined by the Investigator's interpretation of the Subject's medical history. 9. has eschar in the wound that cannot be removed by bedside sharp and/or mechanical debridement. 10. is participating in another interventional clinical trial for the duration of the study. 11. has unexplored fistulas in the wound or fistulas in the wound that connect to other body cavities. 12. has a wound with any tunneling present. 13. has inadequate hemostasis at the wound site, as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in the Percentage of Wound Bed Surface Area (%) Considered Clean, Healthy and Viable From Baseline to Day 6-9 Upon Dressing Removal. | baseline and 6-9 days of treatment | The Absolute Change in the Percentage of Wound bed surface area (cm2) considered to be clean, healthy, and viable from baseline to Day 6-9 upon the final dressing removal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Total Wound Volume (%) From Baseline to Day 6-9 Upon the Final Dressing Removal. | baseline and 6-9 days of treatment | The percent change in total wound volume (%) from baseline to Day 6-9 upon the final dressing removal. |
| Percent Change in Total Wound Area (%) From Baseline to Day 6-9 Upon the Final Dressing Removal. | baseline and 6-9 days of treatment | The percent change in total wound area (%) from baseline to Day 6-9 upon the final dressing removal. |
| Physician Assessment of Need for Wound Debridement | 6-9 days of treatment | Physician assessment of the need for surgical debridement upon completion of study treatment up to Day 6-9. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) V.A.C. VeraFlo Cleanse Choice Dressing, V.A.C.Ulta Therapy Unit and saline solution
Negative Pressure Therapy w/ instillation and dwell (NPWTi-d): Negative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days. | 13 |
| Collagenase Ointment Collagenase Ointment
Collagenase Ointment: Collagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days. | 16 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | eligibility criteria not met | 2 | 0 |
| Overall Study | subject discharged prior to study completion | 1 | 5 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) | Total | Collagenase Ointment |
|---|---|---|---|
| Age, Continuous | 63.2 years STANDARD_DEVIATION 14.02 | 65.5 years STANDARD_DEVIATION 13.37 | 67.4 years STANDARD_DEVIATION 12.97 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 26 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 10 Participants | 5 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 | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 7 Participants | 15 Participants | 8 Participants |
| Region of Enrollment United States | 13 participants | 29 participants | 16 participants |
| Sex: Female, Male Female | 4 Participants | 11 Participants | 7 Participants |
| Sex: Female, Male Male | 9 Participants | 18 Participants | 9 Participants |
| Wound Type Other | 0 Participants | 1 Participants | 1 Participants |
| Wound Type Pressure Ulcer | 11 Participants | 26 Participants | 15 Participants |
| Wound Type Venous leg ulcer | 2 Participants | 2 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 25 |
| other Total, other adverse events | 8 / 17 | 15 / 25 |
| serious Total, serious adverse events | 2 / 17 | 2 / 25 |
Outcome results
Primary
Absolute Change in the Percentage of Wound Bed Surface Area (%) Considered Clean, Healthy and Viable From Baseline to Day 6-9 Upon Dressing Removal.
The Absolute Change in the Percentage of Wound bed surface area (cm2) considered to be clean, healthy, and viable from baseline to Day 6-9 upon the final dressing removal.
Time frame: baseline and 6-9 days of treatment
Population: Modified ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) | Absolute Change in the Percentage of Wound Bed Surface Area (%) Considered Clean, Healthy and Viable From Baseline to Day 6-9 Upon Dressing Removal. | 27.9 percent wound clean healthy viable. | Standard Deviation 34.35 |
| Collagenase Ointment | Absolute Change in the Percentage of Wound Bed Surface Area (%) Considered Clean, Healthy and Viable From Baseline to Day 6-9 Upon Dressing Removal. | 11.6 percent wound clean healthy viable. | Standard Deviation 40.52 |
p-value: 0.292Regression, Linear
Secondary
Percent Change in Total Wound Area (%) From Baseline to Day 6-9 Upon the Final Dressing Removal.
The percent change in total wound area (%) from baseline to Day 6-9 upon the final dressing removal.
Time frame: baseline and 6-9 days of treatment
Population: Modified ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) | Percent Change in Total Wound Area (%) From Baseline to Day 6-9 Upon the Final Dressing Removal. | 0 percent change in wound area | Standard Deviation 0.2 |
| Collagenase Ointment | Percent Change in Total Wound Area (%) From Baseline to Day 6-9 Upon the Final Dressing Removal. | 0.1 percent change in wound area | Standard Deviation 0.96 |
p-value: 0.7422Wilcoxon (Mann-Whitney)
Secondary
Percent Change in Total Wound Volume (%) From Baseline to Day 6-9 Upon the Final Dressing Removal.
The percent change in total wound volume (%) from baseline to Day 6-9 upon the final dressing removal.
Time frame: baseline and 6-9 days of treatment
Population: Modified ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) | Percent Change in Total Wound Volume (%) From Baseline to Day 6-9 Upon the Final Dressing Removal. | -0.3 percent change in wound volume | Standard Deviation 0.59 |
| Collagenase Ointment | Percent Change in Total Wound Volume (%) From Baseline to Day 6-9 Upon the Final Dressing Removal. | 1.3 percent change in wound volume | Standard Deviation 3.27 |
p-value: 0.0213Wilcoxon (Mann-Whitney)
Secondary
Physician Assessment of Need for Wound Debridement
Physician assessment of the need for surgical debridement upon completion of study treatment up to Day 6-9.
Time frame: 6-9 days of treatment
Population: Modified ITT population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) | Physician Assessment of Need for Wound Debridement | Not needing debridement | 3 Participants |
| Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) | Physician Assessment of Need for Wound Debridement | Yes, needing debridement | 10 Participants |
| Collagenase Ointment | Physician Assessment of Need for Wound Debridement | Not needing debridement | 2 Participants |
| Collagenase Ointment | Physician Assessment of Need for Wound Debridement | Yes, needing debridement | 14 Participants |
p-value: 0.6322Fisher Exact