170
Participants
Start Date
August 4, 2020
Primary Completion Date
September 18, 2023
Study Completion Date
September 19, 2023
Investigational device: V.A.C. VERAFLO™ Dressing Kit
"Up to 170 subjects who meet the eligibility criteria will be randomized to the investigational group or control group at the ratio 1:1.~Subjects will only be enrolled following definitive surgical debridement (if serial debridement performed) of the target wound. The target wound for each subject in both groups will be treated for up to 14 days or until deemed ready for closure by the investigator (whichever occurs first). The planned study period consists of the following visits: Screening (Day -3 to 0), Day of randomization (Day0), Dressing change visit(s), End of treatment visit. Following study treatment, the wound may be treated with any standard therapy selected by the physician, and then accepted secondary intervention for wound closure according to the wound bed preparation situation."
Comparator device: Negative pressure wound drainage material
"Up to 170 subjects who meet the eligibility criteria will be randomized to the investigational group or control group at the ratio 1:1.~Subjects will only be enrolled following definitive surgical debridement (if serial debridement performed) of the target wound. The target wound for each subject in both groups will be treated for up to 14 days or until deemed ready for closure by the investigator (whichever occurs first). The planned study period consists of the following visits: Screening (Day -3 to 0), Day of randomization (Day0), Dressing change visit(s), End of treatment visit. Following study treatment, the wound may be treated with any standard therapy selected by the physician, and then accepted secondary intervention for wound closure according to the wound bed preparation situation."
Anhui Provincial Hospital, Hefei
Foshan Hospital of TCM, Foshan
Xi'an Honghui Hospital, Xi’an
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou
KCI USA, Inc
INDUSTRY