Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
KCI USA, Inc
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Pilot RCT of Veraflo With Prontosan vs VAC in Wounds Requiring Operative Debridement
