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 — DEVICE
    Patients 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

Locations (1)

FacilityCityStateZIPSite coordinators
University Nevada - Las VegasLas VegasNevada89102
Michelle Tomasino, CHPSE
702-895-4923
Brian Ward, MD, PhD, FACS (PRINCIPAL_INVESTIGATOR)

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