Trial Outcomes & Findings for Comparison of Two Methods of Securing Skin Grafts Using Negative Pressure Wound Therapy: Vacuum Assisted Closure (VAC) and Gauze Suction (GSUC) (NCT NCT00952120)
NCT ID: NCT00952120
Last Updated: 2015-09-24
Results Overview
For each wound, the percentage of the skin graft that took by Day 4 or 5 was calculated. Complete take is defined as 100% take or skin graft incorporation.
COMPLETED
PHASE3
104 participants
Day 4 or 5
2015-09-24
Participant Flow
104 unique patients were enrolled with a total of 157 wounds (80 of the wounds received GSUC and 77 of the wounds received vacuum-assisted closure).
Participant milestones
| Measure |
GSUC
Continuous negative pressure therapy from the conclusion of the surgery until dressings were taken down on postoperative day 4 or 5. The negative pressure was delivered by low continuous wall suction at 50 to 125 mmHg via a red rubber catheter placed within standardized gauze dressing moistening with sterile saline and sealed with Ioban occlusive dressing.
|
Vacuum-assisted Closure
Continuous negative pressure therapy from the conclusion of the surgery until dressings were taken down on postoperative day 4 or 5. The negative pressure was delivered by the VAC suction unit at 30 to 125 mmHg through a open cell VAC foam dressing sealed with an occlusive cover.
|
GSUC and Vacuum-assisted Closure
These patients had multiple wounds and some of their wounds received GSUC therapy and some of their wounds received VAC.
|
|---|---|---|---|
|
Overall Study
STARTED
|
52
|
47
|
5
|
|
Overall Study
COMPLETED
|
52
|
47
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Two Methods of Securing Skin Grafts Using Negative Pressure Wound Therapy: Vacuum Assisted Closure (VAC) and Gauze Suction (GSUC)
Baseline characteristics by cohort
| Measure |
GSUC
n=52 Participants
Continuous negative pressure therapy from the conclusion of the surgery until dressings were taken down on postoperative day 4 or 5. The negative pressure was delivered by low continuous wall suction at 50 to 125 mmHg via a red rubber catheter placed within standardized gauze dressing moistening with sterile saline and sealed with Ioban occlusive dressing.
|
Vacuum-assisted Closure
n=47 Participants
Continuous negative pressure therapy from the conclusion of the surgery until dressings were taken down on postoperative day 4 or 5. The negative pressure was delivered by the VAC suction unit at 30 to 125 mmHg through a open cell VAC foam dressing sealed with an occlusive cover.
|
GSUC and Vacuum-assisted Closure
n=5 Participants
These patients had multiple wounds and some of their wounds received GSUC therapy and some of their wounds received VAC.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.5 years
STANDARD_DEVIATION 16.5 • n=5 Participants
|
50.1 years
STANDARD_DEVIATION 16.4 • n=7 Participants
|
51.8 years
STANDARD_DEVIATION 20.7 • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 16.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
47 participants
n=7 Participants
|
5 participants
n=5 Participants
|
104 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 4 or 5Population: Some patients had multiple wounds that required skin grafting. Wounds were the unit of analysis, so a participant with multiple wounds could be in both treatment groups which is why the total number of participants adds to more than the number of unique participants enrolled in the study (and included in the participant flow and baseline tables).
For each wound, the percentage of the skin graft that took by Day 4 or 5 was calculated. Complete take is defined as 100% take or skin graft incorporation.
Outcome measures
| Measure |
GSUC
n=80 wounds
Gauze-based wall suction negative pressure wound therapy for 4-5 days
GSUC: Gauze-based wall suction negative pressure wound therapy
|
Vacuum-assisted Closure
n=77 wounds
VAC negative pressure wound therapy using commercially available device (KCI, Inc) for 4-5 days
VAC: Commercially available Wound VAC negative pressure wound therapy device (KCI, Inc.)
|
|---|---|---|
|
Percentage of Wounds With Complete Skin Graft Take
|
80 percentage of wounds
|
78 percentage of wounds
|
SECONDARY outcome
Timeframe: Day 4 or 5Population: Some patients had multiple wounds that required skin grafting. Wounds were the unit of analysis, so a participant with multiple wounds could be in both treatment groups which is why the total number of participants adds to more than the number of unique participants enrolled in the study (and included in the participant flow and baseline tables)
For each wound, whether there was total skin graft loss by Day 4 or 5 was determined.
Outcome measures
| Measure |
GSUC
n=80 wounds
Gauze-based wall suction negative pressure wound therapy for 4-5 days
GSUC: Gauze-based wall suction negative pressure wound therapy
|
Vacuum-assisted Closure
n=77 wounds
VAC negative pressure wound therapy using commercially available device (KCI, Inc) for 4-5 days
VAC: Commercially available Wound VAC negative pressure wound therapy device (KCI, Inc.)
|
|---|---|---|
|
Percentage of Wounds With Total Skin Graft Loss
|
3.8 percentage of wounds
|
1.3 percentage of wounds
|
Adverse Events
GSUC
Vacuum-assisted Closure
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place