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

Launched by ACERA SURGICAL, INC. · Aug 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help patients heal from surgical wounds caused by the removal of skin cancers. Researchers want to see how well a special synthetic material called an electrospun fiber matrix helps these wounds heal over time. The main goal is to measure how long it takes for the wound to completely heal after surgery.

To participate in this trial, you need to be at least 18 years old and scheduled for surgery to remove a skin cancer. Your wound must be between 4 and 36 square centimeters in size. If you meet these criteria and are willing to follow the study requirements, you may be eligible to join. Participants will apply the electrospun fiber matrix to their surgical wounds and then be monitored for healing progress. It's important to know that certain health conditions, like pregnancy or recent cancer treatments, may prevent you from joining the study. Overall, this trial aims to improve healing for patients recovering from skin cancer surgery.

Gender

ALL

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