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

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

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

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries
• Intervention / Treatment: Device: V.A.C.Ulta with Prontosan instillation; Device: V.A.C.Ulta without instillation

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's University Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Health System
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

  1. malignancy in the wound
  2. untreated osteomyelitis
  3. non-enteric or unexplored fistulas
  4. 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)
  5. 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:

  1. Thoracic or abdominal cavities
  2. Unexplored wounds that may communicate with adjacent body cavities
• has a wound that is closed after the initial debridement

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: V.A.C.Ulta with Prontosan instillation; Treatment Arm	Device: V.A.C.Ulta with Prontosan instillation; NPWT with instillation of a wound cleanser (Prontosan® Wound Irrigation Solution)
Active Comparator: V.A.C.Ulta without instillation; Control Arm	Device: V.A.C.Ulta without instillation; NPWT only

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: 3M

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: May 9, 2013
• First Submitted That Met QC Criteria: June 3, 2013
• First Posted (Estimate): June 4, 2013

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: AHS.2011.ULTA.04