Trial Outcomes & Findings for Vashe Wound Therapy Study (NCT NCT00586729)
NCT ID: NCT00586729
Last Updated: 2012-09-14
Results Overview
Percentage area of graft viability at 14 days as determined by clinical assessment of revascularization, adherence of the graft to the wound bed and color
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
14 days
Results posted on
2012-09-14
Participant Flow
Participant milestones
| Measure |
Vashe
Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
|
5% Mafenide Acetate
5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
9
|
|
Overall Study
COMPLETED
|
11
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vashe Wound Therapy Study
Baseline characteristics by cohort
| Measure |
Vashe
n=14 Participants
Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
|
5% Mafenide Acetate
n=9 Participants
5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age Continuous
|
47.0 years
STANDARD_DEVIATION 17.9 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 16.1 • n=7 Participants
|
47.6 years
STANDARD_DEVIATION 17.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
9 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Per protocol
Percentage area of graft viability at 14 days as determined by clinical assessment of revascularization, adherence of the graft to the wound bed and color
Outcome measures
| Measure |
Vashe
n=9 Participants
Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
|
5% Mafenide Acetate
n=7 Participants
5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
|
|---|---|---|
|
Percentage of Grafted Area That is Viable at Day 14
|
96.3 Percentage area
Standard Deviation 7.05
|
96.0 Percentage area
Standard Deviation 3.83
|
SECONDARY outcome
Timeframe: 0 days, 3 days, 5 days and 14 days post-operationPopulation: Per protocol
Average hospital length of stay in days
Outcome measures
| Measure |
Vashe
n=11 Participants
Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
|
5% Mafenide Acetate
n=8 Participants
5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
|
|---|---|---|
|
Length of Stay
|
21.5 Days
Standard Deviation 4.2
|
15.6 Days
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Volume used from admission to dischargePopulation: Per protocol
Average hospital irrigant cost per patient
Outcome measures
| Measure |
Vashe
n=11 Participants
Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
|
5% Mafenide Acetate
n=8 Participants
5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
|
|---|---|---|
|
Hospital Cost Per Patient
|
249.38 Dollars
Standard Deviation 93.43
|
393.00 Dollars
Standard Deviation 176.94
|
Adverse Events
Vashe
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
5% Mafenide Acetate
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vashe
n=11 participants at risk
Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
|
5% Mafenide Acetate
n=8 participants at risk
5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
|
|---|---|---|
|
Infections and infestations
MRSA infection
|
9.1%
1/11
|
0.00%
0/8
|
|
Renal and urinary disorders
Proteinuria
|
9.1%
1/11
|
0.00%
0/8
|
|
Infections and infestations
Cellulitis
|
0.00%
0/11
|
12.5%
1/8
|
Other adverse events
| Measure |
Vashe
n=11 participants at risk
Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
|
5% Mafenide Acetate
n=8 participants at risk
5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hematological abnormality
|
54.5%
6/11
|
62.5%
5/8
|
|
Blood and lymphatic system disorders
Chemistry abnormality
|
63.6%
7/11
|
87.5%
7/8
|
|
Renal and urinary disorders
Urinalysis abnormality
|
90.9%
10/11
|
87.5%
7/8
|
|
Renal and urinary disorders
UTI
|
9.1%
1/11
|
0.00%
0/8
|
|
Reproductive system and breast disorders
Vaginitis
|
9.1%
1/11
|
0.00%
0/8
|
|
Nervous system disorders
Possible seizure
|
9.1%
1/11
|
0.00%
0/8
|
|
Psychiatric disorders
Anxiety
|
9.1%
1/11
|
0.00%
0/8
|
|
Psychiatric disorders
Change in affect
|
18.2%
2/11
|
12.5%
1/8
|
|
Blood and lymphatic system disorders
Coagulation abnormalities
|
18.2%
2/11
|
12.5%
1/8
|
|
Injury, poisoning and procedural complications
Acute pain
|
9.1%
1/11
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Chronic pain
|
0.00%
0/11
|
12.5%
1/8
|
|
Infections and infestations
MRSA infection
|
9.1%
1/11
|
0.00%
0/8
|
|
Infections and infestations
Staph infection
|
9.1%
1/11
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/11
|
12.5%
1/8
|
|
Infections and infestations
Surgical site drainage
|
0.00%
0/11
|
12.5%
1/8
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Fever
|
9.1%
1/11
|
0.00%
0/8
|
|
Cardiac disorders
Chest pain
|
0.00%
0/11
|
12.5%
1/8
|
|
Blood and lymphatic system disorders
Edema
|
0.00%
0/11
|
12.5%
1/8
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/11
|
12.5%
1/8
|
|
Injury, poisoning and procedural complications
Desaturation
|
0.00%
0/11
|
12.5%
1/8
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/11
|
12.5%
1/8
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11
|
12.5%
1/8
|
|
Cardiac disorders
Tachycardia
|
9.1%
1/11
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Hypertrophic granulation tissue
|
9.1%
1/11
|
0.00%
0/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place