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

Wounds and Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01867580
• Other study ID #: AHS.2011.ULTA.04
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: November 2015

Study information

• Verified date: July 2022
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: November 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wounds and Injuries

Intervention

Device:
• V.A.C.Ulta with Prontosan instillation
NPWT with instillation of a wound cleanser (Prontosan® Wound Irrigation Solution)
• V.A.C.Ulta without instillation
NPWT only

Locations

Country	Name	City	State
United States	St. Luke's University Hospital	Bethlehem	Pennsylvania
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	University of Texas Southwestern	Dallas	Texas
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	Medstar Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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