Trial Outcomes & Findings for V.A.C. VeraFlo™ Instillation Therapy vs V.A.C. Ulta™ Therapy on Biofilm in Chronically Infected Wounds (NCT NCT02009501)
NCT ID: NCT02009501
Last Updated: 2018-11-27
Results Overview
Biopsies for bacteria colony-forming units obtained at pre surgical debridement (baseline) and day 7.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Baseline and day 7
Results posted on
2018-11-27
Participant Flow
Recruitment began Nov 2013, with enrollment in Jan 2014 and trial conducted to Nov 2014. All patients were recruited from the outpatient vascular and wound care clinic at Mt Sinai St Luke's - Roosevelt Hospitals in New York City.
Participant milestones
| Measure |
VAC Ulta Therapy
VAC ULTA Therapy applied in the OR after surgical debridement.
|
VAC VeraFlo With Dakins Instillation
VAC VeraFlo with Dakins Instillation.0.125% instillation applied in the OR after surgical debridement.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
|
Overall Study
COMPLETED
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
V.A.C. VeraFlo™ Instillation Therapy vs V.A.C. Ulta™ Therapy on Biofilm in Chronically Infected Wounds
Baseline characteristics by cohort
| Measure |
VAC Ulta Therapy
n=9 Participants
VAC ULTA Therapy applied in the OR after surgical debridement.
|
VAC VeraFlo With Dakins Instillation
n=11 Participants
VAC VeraFlo with Dakins Instillation.0.125% instillation applied in the OR after surgical debridement.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.7 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
62.3 years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
63.83 years
STANDARD_DEVIATION 4.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ulcer duration
|
93.9 months
STANDARD_DEVIATION 42.9 • n=5 Participants
|
103.3 months
STANDARD_DEVIATION 43.3 • n=7 Participants
|
99.07 months
STANDARD_DEVIATION 43.37 • n=5 Participants
|
|
Ulcer size
|
43.5 cm^3
STANDARD_DEVIATION 10.8 • n=5 Participants
|
56.2 cm^3
STANDARD_DEVIATION 17.8 • n=7 Participants
|
50.48 cm^3
STANDARD_DEVIATION 16.33 • n=5 Participants
|
|
Etiology
Venous
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Etiology
Diabetic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Etiology
Mixed
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Comorbidities
Hypertension
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Comorbidities
Diabetes Mellitus
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Comorbidities
Morbid Obesity
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Comorbidities
Chronic Kidney Disease
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Comorbidities
Hyperlipidemia
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Comorbidities
Tobacco use
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and day 7Biopsies for bacteria colony-forming units obtained at pre surgical debridement (baseline) and day 7.
Outcome measures
| Measure |
VAC Ulta Therapy
n=9 Participants
VAC ULTA Therapy applied in the OR after surgical debridement.
|
VAC VeraFlo With Dakins Instillation
n=11 Participants
VAC VeraFlo with Dakins Instillation.0.125% instillation applied in the OR after surgical debridement.
|
|---|---|---|
|
Change in Bacteria Colony-forming Units Using When NPWT and NPWTi on Venous Leg Ulcers
Baseline
|
8.6 10^3 CFU/g
Standard Deviation 8.8
|
12.9 10^3 CFU/g
Standard Deviation 12.5
|
|
Change in Bacteria Colony-forming Units Using When NPWT and NPWTi on Venous Leg Ulcers
7 days post application
|
2.5 10^3 CFU/g
Standard Deviation 5.0
|
3.2 10^3 CFU/g
Standard Deviation 9.4
|
Adverse Events
VAC Ulta Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VAC VeraFlo With Dakins Instillation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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