Actively Recruiting
A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms
Led by Acera Surgical, Inc. · Updated on 2025-05-28
34
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is at least 18 years old
- Patient plans to undergo surgical resection of a cutaneous neoplasm
- Patient is willing and capable of complying with all protocol requirements
- Patient or legally authorized representative is willing to provide written informed consent
- Post-resection surgical wound with a surface area of 64 cm2 and 6 36 cm2
You will not qualify if you...
- Inability to give informed consent or complete study procedures
- Previously enrolled in this study or participating in another ongoing drug or device study
- Pregnant, breastfeeding, or planning pregnancy
- Known allergy to resorbable suture materials like Polyglactin 910 or Polydioxanone
- Received immunotherapy, radiation, or chemotherapy within 4 weeks prior to surgery
- Life expectancy less than 6 months
- Additional wound within 3 cm of study wound
- Study wound located on hands or feet
- Diagnosed with osteomalacia
- Resection defect from squamous cell carcinoma arising from chronic wound
- Uncontrolled thyroid disorder
- Hgb A1c > 12% within 3 months prior for diabetic patients
- BMI over 34.9
- Used tobacco products within 30 days prior to surgery
- Chronic kidney disease on dialysis or very low kidney function
- Severe liver disease with active cirrhosis or high MELD-Na score
- Poor metabolic control as judged by investigator
- History of poor compliance with medical treatment
- History of radiotherapy to wound bed
- Diagnosed with autoimmune connective tissue diseases like lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis
- Active infection, undrained abscess, or critically colonized wound as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Nevada - Las Vegas
Las Vegas, Nevada, United States, 89102
Actively Recruiting
Research Team
M
Matthew MacEwan, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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