V.A.C. VeraFlo™ Instillation Therapy vs V.A.C. Ulta™ Therapy on Biofilm in Chronically Infected Wounds

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Open, Comparative, Randomized Single-center Study to Evaluate the Effect of V.A.C. VeraFlo™ Therapy With .125% Dakins vs V.A.C. Ulta™ Therapy on Biofilm Removal/Disruption/Elimination in Chronically Infected Wounds

Conditions
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Lower Extremity Wound Infected, Venous Stasis Ulcers

Intervention / Treatment
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* Device: VAC VeraFlo with Dakins Instillation
* Device: VAC Ulta Therapy


Participation Criteria
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Eligibility Criteria
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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: Have an ulcer area of at least 4 cm2 confirmed via counting squares on an wound tracing Have been present for at least 4 weeks Are confirmed to have a colony forming unit per gram of wound tissue greater than or equal to 10 to the 5th cfu Are full thicknesses through to dermal or subcutaneous tissue but not extending to muscle or bone. 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. 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) The patient is able to understand the evaluation and is willing to consent to the evaluation. Patients with a suitable wound on a different limb to any other wounds previously eligible. Exclusion Criteria: Patients undergoing chemotherapy Patients being treated with immunosuppressive drugs or corticosteroids Patients with an autoimmune disease Patients who have participated in an experimental drug or device study within the last 15 days Patients that have been entered in this evaluation previously as an evaluable patient.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VAC VeraFlo with Dakins Instillation<br>VAC VeraFlo with Dakins .125% instillation will be initially applied in the OR after surgical debridement. Dressing will be changed on day 4 and and removed on day 7. Wound assessments will continue at weeks 2, 3, and 4. | Device: VAC VeraFlo with Dakins Instillation<br>* 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.<br>* Other names: VAC Instill;|
| Active Comparator: VAC Ulta Therapy<br>VAC ULTA Therapy will be initially applied in the OR after surgical debridement. Dressing will be changed on day 4 and and removed on day 7. Wound assessments will continue at weeks 2, 3, and 4. | Device: VAC Ulta Therapy<br>* 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.<br>* Other names: NPWT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NPWTi, Infected wounds, VAC Instill, Biofilm