Lower Extremity Wound Infected, Venous Stasis Ulcers
Conditions
Keywords
Infected wounds, NPWTi, VAC Instill, Biofilm
Brief summary
This study would like to determine if using negative pressure wound therapy with an instillation of .125% Dakins is more effective than using negative pressure wound therapy alone on biofilm removal, disruption and elimination in chronically infected lower extremity wounds.
Interventions
DEVICEVAC VeraFlo with Dakins Instillation
VAC VeraFlo with Dakins instillation will be placed in the operating room after surgical debridement. Biopsies will be obtained prior to surgical debridement, after surgical debridement, on day 4, and on day 7.
DEVICEVAC Ulta Therapy
VAC ULTA will be placed in the operating room after surgical debridement. Biopsies will be obtained prior to surgical debridement, after surgical debridement, on day 4, and on day 7.
Sponsors
Kinetic Concepts, Inc.
St. Luke's-Roosevelt Hospital Center
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 patient is of 18 years or older. * Males and females - provided they are not pregnant and if of reproductive age are using contraception. * Patient with ulcers that: 1. Have an ulcer area of at least 4 cm2 confirmed via counting squares on an wound tracing 2. Have been present for at least 4 weeks 3. Are confirmed to have a colony forming unit per gram of wound tissue greater than or equal to 10 to the 5th cfu 4. Are full thicknesses through to dermal or subcutaneous tissue but not extending to muscle or bone. 5. The patient has an ABI of greater or equal to 0.8 and lower than 1.3 or has a suitable Peripheral Vascular Resistance (PVR) and Doppler assessment which confirms venous disease & therefore treatment with Profore is deemed acceptable by the clinician. 6. The patient has one or more clinical signs of infection (edema, malodor, local/periwound erythema, spontaneous pain between dressing changes, increased exudate, discoloration of granulation tissue, increased temperature at wound, non progression of wound, purulent exudate and friable granulation tissue) 7. The patient is able to understand the evaluation and is willing to consent to the evaluation. 8. Patients with a suitable wound on a different limb to any other wounds previously eligible.
Exclusion criteria
1. Patients undergoing chemotherapy 2. Patients being treated with immunosuppressive drugs or corticosteroids 3. Patients with an autoimmune disease 4. Patients who have participated in an experimental drug or device study within the last 15 days 5. Patients that have been entered in this evaluation previously as an evaluable patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bacteria Colony-forming Units Using When NPWT and NPWTi on Venous Leg Ulcers | Baseline and day 7 | Biopsies for bacteria colony-forming units obtained at pre surgical debridement (baseline) and day 7. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| VAC Ulta Therapy VAC ULTA Therapy applied in the OR after surgical debridement. | 9 |
| VAC VeraFlo With Dakins Instillation VAC VeraFlo with Dakins Instillation.0.125% instillation applied in the OR after surgical debridement. | 11 |
| Total | 20 |
Baseline characteristics
| Characteristic | Total | VAC VeraFlo With Dakins Instillation | VAC Ulta Therapy |
|---|---|---|---|
| Age, Continuous | 63.83 years STANDARD_DEVIATION 4.89 | 62.3 years STANDARD_DEVIATION 5.8 | 65.7 years STANDARD_DEVIATION 2.4 |
| Comorbidities Chronic Kidney Disease | 3 Participants | 2 Participants | 1 Participants |
| Comorbidities Diabetes Mellitus | 11 Participants | 5 Participants | 6 Participants |
| Comorbidities Hyperlipidemia | 13 Participants | 7 Participants | 6 Participants |
| Comorbidities Hypertension | 13 Participants | 7 Participants | 6 Participants |
| Comorbidities Morbid Obesity | 3 Participants | 2 Participants | 1 Participants |
| Comorbidities Tobacco use | 10 Participants | 7 Participants | 3 Participants |
| Etiology Diabetic | 1 Participants | 1 Participants | 0 Participants |
| Etiology Mixed | 7 Participants | 3 Participants | 4 Participants |
| Etiology Venous | 12 Participants | 7 Participants | 5 Participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 16 Participants | 9 Participants | 7 Participants |
| Ulcer duration | 99.07 months STANDARD_DEVIATION 43.37 | 103.3 months STANDARD_DEVIATION 43.3 | 93.9 months STANDARD_DEVIATION 42.9 |
| Ulcer size | 50.48 cm^3 STANDARD_DEVIATION 16.33 | 56.2 cm^3 STANDARD_DEVIATION 17.8 | 43.5 cm^3 STANDARD_DEVIATION 10.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in Bacteria Colony-forming Units Using When NPWT and NPWTi on Venous Leg Ulcers
Biopsies for bacteria colony-forming units obtained at pre surgical debridement (baseline) and day 7.
Time frame: Baseline and day 7
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VAC Ulta Therapy | 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 |
| VAC Ulta Therapy | 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 |
| VAC VeraFlo With Dakins Instillation | Change in Bacteria Colony-forming Units Using When NPWT and NPWTi on Venous Leg Ulcers | Baseline | 12.9 10^3 CFU/g | Standard Deviation 12.5 |
| VAC VeraFlo With Dakins Instillation | Change in Bacteria Colony-forming Units Using When NPWT and NPWTi on Venous Leg Ulcers | 7 days post application | 3.2 10^3 CFU/g | Standard Deviation 9.4 |