N/A
Completed N=181
A Pilot RCT of Veraflo With Prontosan vs VAC in Wounds Requiring Operative Debridement
Wounds and Injuries
Source: ClinicalTrials.gov NCT01867580 ↗
Enrolled (actual)
181
Serious AEs
22.7%
Results posted
Nov 2017
Primary outcomePrimary: Number of Inpatient Operating Room Debridements — 9; 13; 52; 41 Participants — p=0.6770
Summary
The purpose of this study is to examine the effectiveness of the Veraflo with Prontosan vs VAC in wounds that require operative debridement.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Inpatient Operating Room Debridements |
9; 13; 52; 41; 5; 10 | 0.6770 |
| SECONDARY The Difference in Total Bacterial Counts Measured in Colony Forming Units (CFU) as Determined by Quantitative PCR Analysis. |
-0.18; 0.6 | 0.0202 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01867580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.