A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms
Acera Surgical, Inc.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patient is at least 18 years old 2. Patient plans to undergo surgical resection of a cutaneous neoplasm 3. Patient is willing and capable of complying with all protocol requirements 4. Patient or legally authorized representative (LAR) is willing to provide written informed consent prior to participation in study 5. Post-resection surgical wound with a surface area of ≥4 cm2 and ≤ 36cm2 Exclusion Criteria: 1. Inability to give informed consent or to complete the procedures required for study completion 2. Patient has been previously enrolled into this study, or is cur…
Interventions
- DeviceSynthetic 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
Location
- University Nevada - Las VegasLas Vegas, Nevada