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

Inclusion criteria

• 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 (LAR) is willing to provide written informed consent prior to participation in study
• Post-resection surgical wound with a surface area of ≥4 cm2 and ≤ 36cm2

Exclusion criteria

• Inability to give informed consent or to complete the procedures required for study completion
• 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
• Patient is pregnant, breast feeding or planning to become pregnant
• Patient has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS)
• Patients receiving any immunotherapy, radiation, or chemotherapy within the past four weeks prior to resection surgery.
• Patient has a life expectancy less than six months as assessed by the investigator
• Patient has an additional non-study related wound within 3 cm of the study wound
• Study wound is located on the hands or feet
• Patient has been diagnosed with osteomalacia
• Resection defect from a squamous cell carcinoma arising from a chronic wound
• Patient has an uncontrolled thyroid disorder
• Hgb A1c > 12% within 3 months prior to enrollment in patients with a known history of diabetes
• Patient has a BMI > 34.9
• Patient has used any tobacco product within the past 30 days prior to surgery
• Patients with chronic kidney disease on peritoneal or hemodialysis, or with an estimated glomerular filtration rate less than 15mL/min
• 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
• Patient not in reasonable metabolic control in the judgement of the investigator
• Patient has a known history of poor compliance with medical treatment
• Patient has a history of radiotherapy to wound bed of interest
• Patient has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis
• Active infection, undrained abscess, or critical colonization of the wound with bacteria in the judgement of the investigator