A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms
NCT06578650 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 34
Last updated 2025-05-28
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
- 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
Sponsors & Collaborators
-
Acera Surgical, Inc.
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-31
- Primary Completion
- 2026-11-30
- Completion
- 2027-05-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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