Actively Recruiting
A Prospective, Single-arm Clinical Trial of Electrospun Fiber Matrix (Restrata) for Surgical Defects After Removal of Malignant Skin Tumors
Led by Acera Surgical, Inc. · Updated on 2025-05-28
34
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to observe wound healing outcomes in patients who have had surgical removal of malignant skin tumors. It focuses on wounds treated with a synthetic electrospun fiber matrix and measures how long it takes from the surgery and product application until the wound bed is fully ready for healing, called complete granulation. Participants will receive the synthetic electrospun fiber matrix immediately after their skin tumor is surgically removed. This is a single-group study without a comparison group, where the device is applied to the wound and healing progress is monitored over time. During the study, participants will have weekly assessments for up to six weeks to evaluate wound granulation, pain levels, and the need for skin grafting. Additional follow-up will continue up to 16 weeks to monitor complete wound healing. Researchers will also assess skin graft and tissue flap success one week after those procedures. The total participation time varies depending on healing progress, with regular evaluations throughout.
CONDITIONS
Brief 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 before participation
- Post-resection surgical wound with a surface area of 4 cm2 or larger and 36 cm2 or smaller
You will not qualify if you...
- Inability to give informed consent or complete study procedures
- Previous enrollment in this study or current participation in another drug or device study without primary endpoint reached
- Pregnancy, breastfeeding, or planning to become pregnant
- Known allergy to resorbable suture materials such as Polyglactin 910 or Polydioxanone
- Receiving immunotherapy, radiation, or chemotherapy within four weeks before surgery
- Life expectancy less than six months as assessed by investigator
- Additional non-study related wound within 3 cm of study wound
- Study wound located on hands or feet
- Diagnosis of osteomalacia
- Resection defect from squamous cell carcinoma arising from a chronic wound
- Uncontrolled thyroid disorder
- Hemoglobin A1c greater than 12% within 3 months prior for diabetic patients
- Body mass index over 34.9
- Tobacco use within 30 days before 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
- Prior radiotherapy to wound bed
- Diagnosis of autoimmune connective tissue diseases such as lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis
- Active infection, undrained abscess, or critical bacterial colonization of the wound as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo surgical removal of malignant skin tumors followed by treatment with the Synthetic Electrospun Fiber Matrix applied to the surgical wound.
1 visit (in-person)
Duration - Up to 16 weeks post resection
Participants are monitored weekly for wound healing progress, including assessments of wound bed granulation, pain, and need for skin grafting, until healing or up to 16 weeks post surgery.
Weekly visits for up to 16 weeks
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
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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