Using a synthetic fiber matrix to improve healing of surgical wounds from skin cancer removal

A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms

This study is testing if a special synthetic material can help patients heal faster after having skin cancer surgery.

Quick facts

• Study type: Observational
• Enrollment: 34 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Acera Surgical, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Las Vegas, Nevada)
• Trial ID: NCT06578650 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effectiveness of a synthetic electrospun fiber matrix in promoting wound healing for patients undergoing surgical resection of malignant skin tumors. Participants will have their surgical wounds treated with this innovative material, and the study will measure the time taken for the wounds to achieve complete granulation. The focus is on understanding how this treatment can enhance recovery outcomes in a specific patient population. The study will involve patients aged 18 and older who meet specific eligibility criteria related to their surgical wounds.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are scheduled for surgical resection of a cutaneous neoplasm with a wound size between 4 cm² and 36 cm².

Not a fit: Patients who are pregnant, breastfeeding, or have allergies to specific suture materials may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved healing times and outcomes for patients with surgical wounds from skin cancer removal.

How similar studies have performed: While this approach is innovative, similar studies using synthetic materials for wound healing have shown promise, suggesting potential for success.

Eligibility criteria

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 currently participating in another drug or device study that has not reached its primary endpoint
3. Patient is pregnant, breast feeding or planning to become pregnant
4. Patient has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS)
5. Patients receiving any immunotherapy, radiation, or chemotherapy within the past four weeks prior to resection surgery.
6. Patient has a life expectancy less than six months as assessed by the investigator
7. Patient has an additional non-study related wound within 3 cm of the study wound
8. Study wound is located on the hands or feet
9. Patient has been diagnosed with osteomalacia
10. Resection defect from a squamous cell carcinoma arising from a chronic wound
11. Patient has an uncontrolled thyroid disorder
12. Hgb A1c \> 12% within 3 months prior to enrollment in patients with a known history of diabetes
13. Patient has a BMI \> 34.9
14. Patient has used any tobacco product within the past 30 days prior to surgery
15. Patients with chronic kidney disease on peritoneal or hemodialysis, or with an estimated glomerular filtration rate less than 15mL/min
16. Patients with severe liver disease with active cirrhosis defined as a gross ascites upon clinical exam or a Model for End-stage Liver Disease (MELD)-Na score greater than 15
17. Patient not in reasonable metabolic control in the judgement of the investigator
18. Patient has a known history of poor compliance with medical treatment
19. Patient has a history of radiotherapy to wound bed of interest
20. Patient has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis
21. Active infection, undrained abscess, or critical colonization of the wound with bacteria in the judgement of the investigator

Where this trial is running

Las Vegas, Nevada

• University Nevada - Las Vegas — Las Vegas, Nevada, United States (Recruiting)

Study contacts

• Study coordinator: Matthew MacEwan, PhD

Conditions Surgical Wound