At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective, Multi-center, Randomized, Open Label, Parallel Group Controlled, Non-inferiority Trial Evaluating the Efficacy and Safety of the VERAFLO™ Dressing Kit for Wound Bed Preparation in Open Wounds With Extensive Soft Tissue Damage
In Brief
A clinical study evaluating Investigational device: V.A.C. VERAFLO™ Dressing Kit and Comparator device: Negative pressure wound drainage material for Wound Healing. Completed, enrolled 170 participants across 4 sites.
Detailed Summary
The objectives are to evaluate the efficacy and safety of the V.A.C. VERAFLO™ Dressing Kit for wound bed preparation in open wounds with extensive soft tissue damage in this trial.
Study Details
Timeline
Interventions
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.
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.