Trial Outcomes & Findings for Treatment of Full-Thickness Wounds: NPWT Combined With Type-I Collagen Based Advanced Skin Substitute Versus NPWT Alone (NCT NCT06873867)
NCT ID: NCT06873867
Last Updated: 2025-11-21
Results Overview
Percentage change in wound area from week 1 through week 7 measured manually with digital photography
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
104 participants
Primary outcome timeframe
7 weeks
Results posted on
2025-11-21
Participant Flow
Participant milestones
| Measure |
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy
In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.
High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
Negative Pressure Wound Therapy
In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
52
|
|
Overall Study
COMPLETED
|
52
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy
n=52 Participants
In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.
High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
Negative Pressure Wound Therapy
n=52 Participants
In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Wound etiology, n (%)
Diabetic
|
8 Participants
n=52 Participants
|
10 Participants
n=52 Participants
|
18 Participants
n=104 Participants
|
|
Age, Customized
|
54.1 years
STANDARD_DEVIATION 12.2 • n=52 Participants
|
55.3 years
STANDARD_DEVIATION 11.7 • n=52 Participants
|
54.7 years
STANDARD_DEVIATION 11.9 • n=104 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=52 Participants
|
19 Participants
n=52 Participants
|
37 Participants
n=104 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=52 Participants
|
33 Participants
n=52 Participants
|
67 Participants
n=104 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
India
|
52 participants
n=52 Participants
|
52 participants
n=52 Participants
|
104 participants
n=104 Participants
|
|
Wound area (cm²)
|
32.8 square centimeters
STANDARD_DEVIATION 18.5 • n=52 Participants
|
33.6 square centimeters
STANDARD_DEVIATION 17.9 • n=52 Participants
|
33.18 square centimeters
STANDARD_DEVIATION 18.11 • n=104 Participants
|
|
Wound duration (weeks)
|
4.1 weeks
STANDARD_DEVIATION 2.9 • n=52 Participants
|
5.1 weeks
STANDARD_DEVIATION 3.1 • n=52 Participants
|
4.6 weeks
STANDARD_DEVIATION 3.0 • n=104 Participants
|
|
Wound etiology, n (%)
Traumatic
|
12 Participants
n=52 Participants
|
14 Participants
n=52 Participants
|
26 Participants
n=104 Participants
|
|
Wound etiology, n (%)
Surgical
|
10 Participants
n=52 Participants
|
10 Participants
n=52 Participants
|
20 Participants
n=104 Participants
|
|
Wound etiology, n (%)
Burns
|
8 Participants
n=52 Participants
|
8 Participants
n=52 Participants
|
16 Participants
n=104 Participants
|
|
Wound etiology, n (%)
Vascular
|
7 Participants
n=52 Participants
|
5 Participants
n=52 Participants
|
12 Participants
n=104 Participants
|
|
Wound etiology, n (%)
Pressure
|
7 Participants
n=52 Participants
|
5 Participants
n=52 Participants
|
12 Participants
n=104 Participants
|
|
Wound location, n (%)
Lower Limb
|
28 Participants
n=52 Participants
|
23 Participants
n=52 Participants
|
51 Participants
n=104 Participants
|
|
Wound location, n (%)
Chest
|
10 Participants
n=52 Participants
|
9 Participants
n=52 Participants
|
19 Participants
n=104 Participants
|
|
Wound location, n (%)
Upper limb
|
8 Participants
n=52 Participants
|
12 Participants
n=52 Participants
|
20 Participants
n=104 Participants
|
|
Wound location, n (%)
Abdomen
|
4 Participants
n=52 Participants
|
5 Participants
n=52 Participants
|
9 Participants
n=104 Participants
|
|
Wound location, n (%)
Back
|
2 Participants
n=52 Participants
|
3 Participants
n=52 Participants
|
5 Participants
n=104 Participants
|
|
Wound location, n (%)
Head and Neck
|
0 Participants
n=52 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=104 Participants
|
PRIMARY outcome
Timeframe: 7 weeksPercentage change in wound area from week 1 through week 7 measured manually with digital photography
Outcome measures
| Measure |
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy
n=52 Participants
In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.
High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
Negative Pressure Wound Therapy
n=52 Participants
In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
|---|---|---|
|
Percentage Change in Wound Area
Wound area reduction at 6 weeks
|
78.33 percentage change
Standard Deviation 16.98
|
50.83 percentage change
Standard Deviation 13.72
|
|
Percentage Change in Wound Area
Wound area reduction at 7 weeks
|
89.35 percentage change
Standard Deviation 16.08
|
57.85 percentage change
Standard Deviation 12.73
|
|
Percentage Change in Wound Area
Wound area reduction at 1 week
|
23.73 percentage change
Standard Deviation 11.45
|
15.21 percentage change
Standard Deviation 9.32
|
|
Percentage Change in Wound Area
Wound area reduction at 2 weeks
|
34.47 percentage change
Standard Deviation 13.28
|
22.52 percentage change
Standard Deviation 10.85
|
|
Percentage Change in Wound Area
Wound area reduction at 3 weeks
|
45.17 percentage change
Standard Deviation 14.67
|
29.85 percentage change
Standard Deviation 11.98
|
|
Percentage Change in Wound Area
Wound area reduction at 4 weeks
|
56.45 percentage change
Standard Deviation 15.82
|
36.62 percentage change
Standard Deviation 12.74
|
|
Percentage Change in Wound Area
Wound area reduction at 5 weeks
|
67.14 percentage change
Standard Deviation 16.45
|
43.97 percentage change
Standard Deviation 13.28
|
SECONDARY outcome
Timeframe: 5 daysHistopathological assessment will be done using biopsy on Day 0 of application to be compared with Day 5 after application of Type-I Collagen-based Skin Substitute or Human Amnion/Chorion Membrane. Histopathology assessed at day 0 and day 5, day 5 reported. Subsequently histopathology of biopsy will be done to look for: vascular infiltration (0-3 scale) - higher score means better, neo-epithelialization (0-3 scale) - higher score means better, fibroblast activity (0-3 scale) - higher score means better, inflammatory response (0-3 scale) - lower score means better and collagen deposition (0-3 scale) - higher score means better
Outcome measures
| Measure |
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy
n=52 Participants
In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.
High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
Negative Pressure Wound Therapy
n=52 Participants
In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
|---|---|---|
|
Histopathological Analysis on Day 5 of Study
vascular infiltration (0-3 scale)
|
2.82 score on a scale
Standard Deviation 0.65
|
2.10 score on a scale
Standard Deviation 0.58
|
|
Histopathological Analysis on Day 5 of Study
neo-epithelialization (0-3 scale)
|
2.73 score on a scale
Standard Deviation 0.61
|
1.72 score on a scale
Standard Deviation 0.54
|
|
Histopathological Analysis on Day 5 of Study
fibroblast activity (0-3 scale)
|
2.79 score on a scale
Standard Deviation 0.68
|
1.63 score on a scale
Standard Deviation 0.52
|
|
Histopathological Analysis on Day 5 of Study
inflammatory response (0-3 scale)
|
1.32 score on a scale
Standard Deviation 0.48
|
2.35 score on a scale
Standard Deviation 0.63
|
|
Histopathological Analysis on Day 5 of Study
collagen deposition (0-3 scale)
|
2.78 score on a scale
Standard Deviation 0.64
|
1.43 score on a scale
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: 5 daysHistopathological assessment will be done using biopsy on Day 0 of application to be compared with Day 5 after application of Type-I Collagen-based Skin Substitute or Human Amnion/Chorion Membrane. Histopathology assessed at day 0 and day 5, day 5 reported. Subsequently histopathology of biopsy will be done to look for capillary density (vessels per mm²) - higher count means better,
Outcome measures
| Measure |
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy
n=52 Participants
In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.
High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
Negative Pressure Wound Therapy
n=52 Participants
In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
|---|---|---|
|
Histopathological Analysis on Day 5 of Study - Capillary Density
|
48.51 vessels per mm²
Standard Deviation 8.32
|
42.97 vessels per mm²
Standard Deviation 7.85
|
SECONDARY outcome
Timeframe: 7 weeksThe time to achieve complete wound closure of the target ulcer by the end of 7 weeks
Outcome measures
| Measure |
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy
n=52 Participants
In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.
High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
Negative Pressure Wound Therapy
n=52 Participants
In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
|---|---|---|
|
Time to Achieve Complete Wound Closure
|
36.81 days
Standard Deviation 12.88
|
43.94 days
Standard Deviation 16.70
|
SECONDARY outcome
Timeframe: 7 weeksThe percentage of participants that obtain complete wound closure over the 7 weeks (6 weeks treatment period plus 1 week follow up)
Outcome measures
| Measure |
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy
n=52 Participants
In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.
High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
Negative Pressure Wound Therapy
n=52 Participants
In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
|---|---|---|
|
Percentage of Participants to Obtain Complete Wound Closure
|
45 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 7 weeksMeasurement of percentage of participants achieving ≥50% wound healing (epithelialization) assessed at follow up
Outcome measures
| Measure |
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy
n=52 Participants
In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.
High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
Negative Pressure Wound Therapy
n=52 Participants
In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
|---|---|---|
|
Percentage of Participants Achieving ≥50% Wound Healing
|
49 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 6 weeksMean number of rapplications of the NPWT+HPTC \& NPWT alone used to obtain wound closure
Outcome measures
| Measure |
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy
n=52 Participants
In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.
High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
Negative Pressure Wound Therapy
n=52 Participants
In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
|---|---|---|
|
Mean Number of Application
|
1.83 number of applications
Standard Deviation 0.82
|
4.3 number of applications
Standard Deviation 1.72
|
SECONDARY outcome
Timeframe: 6 weeksNumber of adverse events related to the intervention (e.g., infection, allergic reactions, NPWT seal issues)
Outcome measures
| Measure |
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy
n=52 Participants
In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.
High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
Negative Pressure Wound Therapy
n=52 Participants
In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
|---|---|---|
|
Number of Adverse Events
Superficial wound infection
|
2 number of adverse events
|
3 number of adverse events
|
|
Number of Adverse Events
Skin irritation around wound
|
1 number of adverse events
|
1 number of adverse events
|
|
Number of Adverse Events
NPWT seal issues
|
1 number of adverse events
|
2 number of adverse events
|
|
Number of Adverse Events
Allergic reaction
|
1 number of adverse events
|
0 number of adverse events
|
|
Number of Adverse Events
Pain during dressing change
|
0 number of adverse events
|
2 number of adverse events
|
|
Number of Adverse Events
Severe infection requiring IV antibiotics
|
0 number of adverse events
|
0 number of adverse events
|
SECONDARY outcome
Timeframe: 7 weeksPain measured by a Visual Analog Scale with score range from 0 to 10, wherein 0="no pain" to 10="severe pain"
Outcome measures
| Measure |
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy
n=52 Participants
In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.
High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
Negative Pressure Wound Therapy
n=52 Participants
In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
|---|---|---|
|
Pain Score on Visual Analog Scale
Week 2
|
5.71 scores on a scale
Standard Deviation 1.72
|
5.97 scores on a scale
Standard Deviation 1.85
|
|
Pain Score on Visual Analog Scale
Week 3
|
4.73 scores on a scale
Standard Deviation 1.68
|
5.37 scores on a scale
Standard Deviation 1.79
|
|
Pain Score on Visual Analog Scale
Week 4
|
3.98 scores on a scale
Standard Deviation 1.62
|
4.94 scores on a scale
Standard Deviation 1.75
|
|
Pain Score on Visual Analog Scale
Week 5
|
2.86 scores on a scale
Standard Deviation 1.58
|
4.28 scores on a scale
Standard Deviation 1.72
|
|
Pain Score on Visual Analog Scale
Week 6
|
1.96 scores on a scale
Standard Deviation 1.52
|
3.83 scores on a scale
Standard Deviation 1.68
|
|
Pain Score on Visual Analog Scale
Week 7
|
1.51 scores on a scale
Standard Deviation 1.48
|
3.17 scores on a scale
Standard Deviation 1.65
|
|
Pain Score on Visual Analog Scale
Week 1
|
6.36 scores on a scale
Standard Deviation 1.78
|
6.42 scores on a scale
Standard Deviation 1.82
|
|
Pain Score on Visual Analog Scale
Baseline
|
7.38 scores on a scale
Standard Deviation 1.85
|
7.16 scores on a scale
Standard Deviation 1.92
|
SECONDARY outcome
Timeframe: 7 weeksThe resultant new skin is assessed and documented at each visit using the Vancouver Scar Scale, up to 7 weeks, week 7 visit reported, assessing vascularity, pigmentation, pliability and height/thickness with total score ranging from 0 to 13 (lesser the score better the scar)
Outcome measures
| Measure |
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy
n=52 Participants
In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.
High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
Negative Pressure Wound Therapy
n=52 Participants
In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
|---|---|---|
|
Healed Wound Appearance Assessment Using Vancouver Scar Scale
|
3.9 scores on a scale
Standard Deviation 1.8
|
9.2 scores on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 7 weeksThe EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument is a standardized patient-reported outcome measure assessing overall health-related quality of life. It evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scoring and Ranges: 1. EQ-5D-5L Index Score - Derived from the five dimensions with five levels each (1 = no problems; 5 = extreme problems). The index score range varies by population value set; for most countries the possible scoring range is approximately -0.594 to 1.000. Higher scores indicate better health status (1.000 = full health). 2. EQ Visual Analogue Scale (EQ-VAS) - A self-rated health scale from 0 to 100, where, 0 = the worst health you can imagine, 100 = the best health you can imagine. Higher values reflect better outcomes. Interpretation: Higher scores on both the EQ-5D-5L Index and EQ-VAS represent improved quality of life and a better treatment outcome.
Outcome measures
| Measure |
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy
n=52 Participants
In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.
High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
Negative Pressure Wound Therapy
n=52 Participants
In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
|---|---|---|
|
Quality of Life Assessment
EQ-5D Index Score
|
0.91 scores on a scale
Standard Deviation 0.102
|
0.71 scores on a scale
Standard Deviation 0.116
|
|
Quality of Life Assessment
EQ-VAS (0-100)
|
88.2 scores on a scale
Standard Deviation 8.3
|
72.1 scores on a scale
Standard Deviation 9.0
|
Adverse Events
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Negative Pressure Wound Therapy
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy
n=52 participants at risk
In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.
High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
Negative Pressure Wound Therapy
n=52 participants at risk
In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Superficial wound infection
|
3.8%
2/52 • 6-week treatment period + 1-week follow-up. Total 7 weeks
All the study participants were considered at risk for adverse events.
|
5.8%
3/52 • 6-week treatment period + 1-week follow-up. Total 7 weeks
All the study participants were considered at risk for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin irritation around wound
|
1.9%
1/52 • 6-week treatment period + 1-week follow-up. Total 7 weeks
All the study participants were considered at risk for adverse events.
|
1.9%
1/52 • 6-week treatment period + 1-week follow-up. Total 7 weeks
All the study participants were considered at risk for adverse events.
|
|
Product Issues
NPWT seal issues
|
1.9%
1/52 • 6-week treatment period + 1-week follow-up. Total 7 weeks
All the study participants were considered at risk for adverse events.
|
3.8%
2/52 • 6-week treatment period + 1-week follow-up. Total 7 weeks
All the study participants were considered at risk for adverse events.
|
|
Skin and subcutaneous tissue disorders
Allergic reaction
|
1.9%
1/52 • 6-week treatment period + 1-week follow-up. Total 7 weeks
All the study participants were considered at risk for adverse events.
|
0.00%
0/52 • 6-week treatment period + 1-week follow-up. Total 7 weeks
All the study participants were considered at risk for adverse events.
|
|
Skin and subcutaneous tissue disorders
Pain during dressing change
|
0.00%
0/52 • 6-week treatment period + 1-week follow-up. Total 7 weeks
All the study participants were considered at risk for adverse events.
|
3.8%
2/52 • 6-week treatment period + 1-week follow-up. Total 7 weeks
All the study participants were considered at risk for adverse events.
|
Additional Information
Dr Naveen N
Adichunchanagiri Institute of Medical Sciences
Phone: +91-9980023372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place