NCT06787690

Multicenter Single-arm Trial to Investigate Clinical Outcomes When Cohealyx™ is Used for Full Thickness Wounds

A Prospective Multicenter Single-arm Clinical Study to Investigate Clinical Outcomes When Cohealyx™ is Used for the Management of Full Thickness Wounds Post-surgical Excision

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Avita Medical · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The goal of this study is to look at clinical outcomes when Cohealyx Collagen Matrix is used to treat full thickness wounds after surgical excision in patients that require a skin graft to heal their wounds. The main question it aims to answer is how long does it take for Cohealyx to support definitive closure.

Detailed description

This is a prospective single-arm post-market multicenter study to evaluate clinical outcomes of Cohealyx when used to manage full thickness wounds post-surgical excision. A systematic literature review and meta-analysis were conducted to establish a performance goal for the primary effectiveness endpoint (time to autografting). Patients with a full thickness wound where autografting is clinically indicated will be considered for participation in this study. Patients will undergo a staged surgical procedure for wound closure. In the first surgery, Cohealyx will be applied to the surgically excised wound bed within 5-days post-injury. Following placement of Cohealyx, investigators will evaluate the wound every 3 days. Once Cohealyx has successfully integrated into the wound bed, as indicated by a robust vascularized tissue bed, the wound bed will be prepared and autografted per the investigative site's standard of care. The study area will be evaluated with respect to Cohealyx integration, time to autografting, autograft take, healing, and safety-related adverse events. Post-autografting, subjects will be followed for 6.5 months. Treatment-related and serious adverse events will be reported through the duration of the study. At all visits, subjects' study treatment areas as well as any donor sites dressed in PermeaDerm will be documented using digital photography.

Conditions

• Burn
• Trauma Wound
• Full Thickness Wounds
• Surgical Wound

Interventions

Type	Name	Description
DEVICE	Cohealyx	Cohealyx application, followed by autologous split-thickness skin graft

Timeline

• Start date: 2025-05-15
• Primary completion: 2026-02-10
• Completion: 2026-08-01
• First posted: 2025-01-22
• Last updated: 2026-03-12

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated device study