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

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

NCT06578650•Acera Surgical, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 more criteria

Locations (1)

University Nevada - Las Vegas

Las Vegas, Nevada, United States

Key Dates

Start Date

October 31, 2024

Primary Completion Date

November 1, 2026

Completion Date

May 1, 2027

Last Updated

May 28, 2025

Enrollment

ESTIMATED participants

Conditions

Surgical Wound

Interventions

Synthetic Electrospun Fiber Matrix

DEVICE

Contacts

Matthew MacEwan, PhD

CONTACT

440-477-1890 macewan@acera-surgical.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Exclusion Criteria

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