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

Not Applicable

Completed

Conditions: Wounds and Injuries

Interventions: Device: V.A.C.Ulta with Prontosan instillation
Device: V.A.C.Ulta without instillation

Registration Number: NCT01867580

Lead Sponsor: KCI USA, Inc

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 181

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
V.A.C.Ulta with Prontosan instillation	V.A.C.Ulta with Prontosan instillation	Treatment Arm
V.A.C.Ulta without instillation	V.A.C.Ulta without instillation	Control Arm

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7): Northwestern University
🇺🇸
Chicago, Illinois, United States
University of Miami Miller School of Medicine
🇺🇸
Miami, Florida, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
St. Luke's University Hospital
🇺🇸
Bethlehem, Pennsylvania, United States
University of Pennsylvania Health System
🇺🇸
Philadelphia, Pennsylvania, United States
University of Texas Southwestern
🇺🇸
Dallas, Texas, United States
Medstar Georgetown University Hospital
🇺🇸
Washington, District of Columbia, United States