Status:
COMPLETED
A Pilot RCT of Veraflo With Prontosan vs VAC in Wounds Requiring Operative Debridement
Lead Sponsor:
KCI USA, Inc
Conditions:
Wounds and Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to examine the effectiveness of the Veraflo with Prontosan vs VAC in wounds that require operative debridement.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT01867580
Start Date
May 1 2013
End Date
November 1 2015
Last Update
December 2 2024
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
2
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
3
Northwestern University
Chicago, Illinois, United States, 60611
4
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115