Clinical trial NCT01867580: A Pilot RCT of Veraflo With Prontosan vs VAC in Wounds Requiring Operative Debridement
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wounds and Injuries
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
First posted: 2013-06-04
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Number of Inpatient Operating Room Debridements
timeFrame: until the wound is deemed ready for closure or coverage by the investigator up to 64 days
Secondary outcomes:
measure: The Difference in Total Bacterial Counts Measured in Colony Forming Units (CFU) as Determined by Quantitative PCR Analysis.
timeFrame: Immediately following initial post debridement to the first dressing change up to 72 hours
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Bethlehem
country: United States
facility: St. Luke's University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
Study officials:
References: