NCT05902793

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

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: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: KCI USA, Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The management of wounds represents a significant challenge in healthcare. There are many considerations necessary in developing the optimal treatment plan for achieving wound care goals. Current standard wound treatment in the management of wounds may involve clinical assessment, debridement, antibiotic treatment and local application of antiseptics or antimicrobials, and drainage. The choice of therapeutic modality is one of many important decisions. Over time, wound care has progressed from the use of products such as dry gauze to advanced moist wound therapies and further to active wound healing therapies. One of such advanced wound healing therapies is negative pressure wound therapy (NPWT), which was developed in the 1990s. NPWT is a technology that is currently widely used in wound care and is promoted for use on complex wounds (open wounds). The therapy of NPWT and solution instillation with a dwell time (NPWTi-d) is used to adjunctively treat high-risk wounds that would benefit from vacuum-assisted drainage and controlled repeated delivery of topical wound solutions, such as normal saline and wound cleansers. Evidences suggests that normal saline is effective and readily available. V.A.C. VERAFLO™ Dressing Kit, which was the investigational device, was a reticulated open-cell foam polyurethane ester dressing that could deliver normal saline instillation solution to the wound site for NPWTi-d therapy. The V.A.C. VERALFO™ Dressing Kit was approved in July 2010 by the U.S Food and Drug Administration (U.S. FDA) and December 2022 by the China National Medical Products Administration (NMPA). This trial was designed as a pre-marketing trial of the V.A.C. VERAFLO™ Dressing Kit in China for NMPA registration. The device V.A.C. VERALFO™ Dressing Kit did not get NMPA approval when the study was initiated. On December 20th, 2022, it was approved by NMPA (Registration No.: 国械注进 20223140619). There were no approved NPWTi-d dressings in China market during protocol design, so a negative pressure wound drainage material manufactured by Guangdong Shuangling Pharmaceutical Co., Ltd. was selected as the control group treatment device, which can apply the NPWT therapy with wall suction.

Conditions

• Wound Healing

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-08-04
• Primary completion: 2023-09-18
• Completion: 2023-09-19
• First posted: 2023-06-15
• Last updated: 2025-03-11
• Results posted: 2024-12-19

Locations

4 sites across 1 country: China

Regulatory

• FDA-regulated device study