A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms
Part of paid clinical trials in Las Vegas, Nevada.
- Sponsor
- Acera Surgical, Inc.
- Study ID
- NCT06578650
- Status
- Recruiting
Conditions
- Surgical Wound
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Synthetic Electrospun Fiber Matrix — DEVICEPatients who are eligible for enrollment will be treated with Synthetic Electrospun Fiber Matrix immediately after surgical resection to the resulting wound
Study Details
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.
Key Dates
- Start date
- Oct 31, 2024
- Status verified
- May 2025
- Primary completion
- Nov 30, 2026
- Completion
- May 31, 2027
Study Design
- Enrollment
- 34 participants (estimated)
Primary Outcome Measure
Time to wound bed granulation [ Time Frame: Weekly assessments until granulation achieved or up to 6 weeks following resection surgery ]
Central Contacts
- Matthew MacEwan, PhD440-477-1890
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University Nevada - Las Vegas | Las Vegas | Nevada | 89102 | Brian Ward, MD, PhD, FACS (PRINCIPAL_INVESTIGATOR) |
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