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

Wound Healing Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This is a prospective, multicenter, randomized (1:1), open-label, parallel controlled, non-inferiority trial evaluating the efficacy and safety of V.A.C. VERAFLO™ Dressing Kit versus Negative Pressure Wound Drainage Material (Guangdong Shuangling Pharmaceuticals Co., Ltd.) for wound bed preparation in open wounds with extensive soft tissue damage. This is a pre-marketing trial of V.A.C. VERAFLO™ Dressing Kit in China for National Medical Products Administration (NMPA) registration. It is anticipated that the primary efficacy endpoint (wound volume reduction rate) of investigational group is non-inferior to that of control group. Up to 170 subjects who meet the eligibility criteria will be randomized to the investigational group or control group at the ratio 1:1.

Debridement is not permitted during study treatment. Therefore, 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). 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. 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. The following data in both groups will be recorded and collected: wound volume reduction rate, time to completion of wound bed preparation, wound area reduction rate, incidence of AEs / SAEs and device deficiencies. The efficacy and safety of V.A.C. VERAFLO™ Dressing Kit in treating open wounds that have extensive soft tissue damage will be evaluated according above data. ;

Related Conditions & MeSH terms

• Wound Healing
• Wounds and Injuries

• NCT number: NCT05902793
• Study type: Interventional
• Source: 3M
• Contact: Yajuan Gong, PM
• Phone: +86 021-22105373
• Email: ygong3@mmm.com
• Status: Recruiting
• Phase: N/A
• Start date: August 11, 2020
• Completion date: October 21, 2023