a pilot rct of veraflo with prontosan vs vac in wounds requiring operative debridement

Conditions: Wounds and Injuries

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