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

Trial 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

NCT ID: NCT06578650

Condition: Surgical Wound

Conditions: Official terms:
Neoplasms
Skin Neoplasms
Surgical Wound

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Device
Intervention name: Synthetic Electrospun Fiber Matrix
Description: Patients who are eligible for enrollment will be treated with Synthetic Electrospun Fiber Matrix immediately after surgical resection to the resulting wound

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.

Criteria for eligibility:

Study pop:
Patients will be enrolled in a University Hospital Setting

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University Nevada - Las Vegas

Address:
City: Las Vegas
Zip: 89102
Country: United States

Status: Recruiting

Contact:
Last name: Michelle Tomasino, CHPSE

Phone: 702-895-4923
Email: michelle.tomasino@unlv.edu

Investigator:
Last name: Brian Ward, MD, PhD, FACS
Email: Principal Investigator

Start date: October 31, 2024

Completion date: August 2025

Lead sponsor:
Agency: Acera Surgical, Inc.
Agency class: Industry

Source: Acera Surgical, Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06578650