Evaluating the Efficacy and Safety of the VERAFLO™ Dressing Kit for Wound Bed Preparation in Open Wounds

NACompletedINTERVENTIONAL
Enrollment

170

Participants

Timeline

Start Date

August 4, 2020

Primary Completion Date

September 18, 2023

Study Completion Date

September 19, 2023

Conditions
Wound Healing
Interventions
DEVICE

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."

DEVICE

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."

Trial Locations (4)

Unknown

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

All Listed Sponsors
lead

KCI USA, Inc

INDUSTRY

NCT05902793 - Evaluating the Efficacy and Safety of the VERAFLO™ Dressing Kit for Wound Bed Preparation in Open Wounds | Biotech Hunter | Biotech Hunter