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

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