Status:
RECRUITING
A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms
Lead Sponsor:
Acera Surgical, Inc.
Conditions:
Surgical Wound
Eligibility:
All Genders
18+ years
Brief 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 electrospu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 31 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06578650
Start Date
October 31 2024
End Date
May 1 2027
Last Update
May 28 2025
Active Locations (1)
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1
University Nevada - Las Vegas
Las Vegas, Nevada, United States, 89102