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

This is an interventional treatment trial for Wounds and Injuries Read More

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