RecruitingNCT06578650

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

Sponsor

Acera Surgical, Inc.

Enrollment

34 participants

Start Date

Oct 31, 2024

Study Type

OBSERVATIONAL

Conditions

Surgical 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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria21

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

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Interventions

DEVICESynthetic Electrospun Fiber Matrix

Patients who are eligible for enrollment will be treated with Synthetic Electrospun Fiber Matrix immediately after surgical resection to the resulting wound