NCT06578650

A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 34 (estimated)
• Sponsor: Acera Surgical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational prospective study is to evaluate wound healing outcomes in resection wounds resulting from surgical removal of cutaneous malignancies treated with a synthetic electrospun fiber matrix. This study intends to quantify the time from initial resection and product application to time of complete granulation of the wound bed in weeks.

Conditions

• Surgical Wound

Interventions

Type	Name	Description
DEVICE	Synthetic Electrospun Fiber Matrix	Patients who are eligible for enrollment will be treated with Synthetic Electrospun Fiber Matrix immediately after surgical resection to the resulting wound

Timeline

• Start date: 2024-10-31
• Primary completion: 2026-11-01
• Completion: 2027-05-01
• First posted: 2024-08-29
• Last updated: 2025-05-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study