A Pilot RCT of Veraflo With Prontosan vs VAC in Wounds Requiring Operative Debridement

Study Overview
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Brief Summary
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The purpose of this study is to examine the effectiveness of the Veraflo with Prontosan vs VAC in wounds that require operative debridement.

Official Title
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A Prospective, Randomized, Multi-Center Trial Evaluating the Effectiveness of the V.A.C. Ulta Negative Pressure Wound Therapy System With V.A.C. VeraFlo Dressing System in Operatively Debrided Wounds

Conditions
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Wounds and Injuries

Intervention / Treatment
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* Device: V.A.C.Ulta with Prontosan instillation
* Device: V.A.C.Ulta without instillation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The Subject: has a wound prior to informed consent will be admitted as an inpatient is >= 18 years of age at time of consent is able to provide his/her own informed consent is willing and able to return for all scheduled and required study visits has an open wound >= 4cm in any plane of measurement excluding tunnels after initial surgical debridement has a wound that is appropriate for NPWT according to approved indications for use has not participated in a clinical trial within the past 30 days has a 30 day wound history available if the wound has been previously treated Exclusion Criteria: The Subject: is pregnant as determined by a positive serum or urine pregnancy test at the time of screening has a life expectancy of < 12 months is not healthy enough to undergo surgery for any reason has, in the investigator's opinion, any clinically significant condition that would impair the participant's ability to comply with the study procedures has, in the opinion of the investigator, a condition that will not allow the subject to tolerate the therapy (e.g. painful conditions such as vasculitis) has rheumatoid arthritis has a bleeding disorder or coagulopathy has a wound that contains antibiotic cement or beads has an ischemic lower extremity wound as determined by lack of detectable pulses in the extremity or ankle-brachial pressure indices of < 0.9 with a history of diabetes, or < 0.6 if the subject is non-diabetic has a known allergy or hypersensitivity to V.A.C. Therapy dressing components including polyurethane or polyvinyl alcohol (drape and foam), or materials that contain acrylic adhesive (drape adhesive) has a known allergy or hyper sensitivity to 3M Cavilon No Sting Barrier Film or any of its components including Hexamethyldisiloxane, isooctane, acrylate terpolymer, polyphenylmethysiloxane, copolymer has a know allergy or hypersensitivity to Prontosan or any of its components including polyhexamethylene biguanide (PHMB), or undecylenamidopropyl betaine has received NPWT on the study wound within the last 30 days has a wound that is contraindicated with Prontosan a. presence of hyaline cartilage in the wound has a wound that is contraindicated with V.A.C. Therapy including: malignancy in the wound untreated osteomyelitis non-enteric or unexplored fistulas necrotic tissue with eschar remaining in the wound after debridement (NOTE: Once necrotic tissue or eschar is removed from the wound bed, subjects may be included) unprotected, exposed blood vessels, anastomotic sites, organs, or nerves in direct contact with foam use of intervening layers between the wound bed and foam has a wound that is contraindicated with V.A.C. VeraFlo Therapy including: Thoracic or abdominal cavities Unexplored wounds that may communicate with adjacent body cavities has a wound that is closed after the initial debridement

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 |
| --- | --- |
| Experimental: V.A.C.Ulta with Prontosan instillation<br>Treatment Arm | Device: V.A.C.Ulta with Prontosan instillation<br>* NPWT with instillation of a wound cleanser (Prontosan® Wound Irrigation Solution)<br>|
| Active Comparator: V.A.C.Ulta without instillation<br>Control Arm | Device: V.A.C.Ulta without instillation<br>* NPWT only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Inpatient Operating Room Debridements | Debridement in this outcome refers to surgical removal of non viable tissue performed in an operating room | until the wound is deemed ready for closure or coverage by the investigator up to 64 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Difference in Total Bacterial Counts Measured in Colony Forming Units (CFU) as Determined by Quantitative PCR Analysis. |  | Immediately following initial post debridement to the first dressing change up to 72 hours |