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 | Recruiting FDA Device

• 1 other identifier: 24-RES-002
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Surgical Wound

Outcome Measures

Primary Outcomes (1)

• Time to wound bed granulation

  Time from initial resection and product placement to the time of at least 75% wound bed granulation using a modified Bates-Jenson Scale. The Bates-Jenson Scale for Granulation Tissue ranges from: 1=Skin intact or partial thickness wound, to: 5=No granulation tissue present. Wounds are considered "granulated" upon receiving a rating of 2 (Bright, beefy red;75% to 100% of wound filled \&/or tissue overgrowth) or less upon investigator assessment. Lower scores are indicative of better outcomes.

  Weekly assessments until granulation achieved or up to 6 weeks following resection surgery

Secondary Outcomes (5)

• Time to complete wound healing

  Until healed or until 16 weeks post resection

• Patient pain

  Weekly for up to six weeks post resection

• Time to skin grafting

  Weekly for up to 6 weeks post-resection

• Skin graft "take" rate

  1 week after skin graft application

• Tissue flap take rate

  1 week after tissue flap procedure

Other Outcomes (5)

• Scar quality

  At the time of complete wound closure and at the 6 month post-resection follow up

• Infection rate and severity

  to be assessed at each visit for up to 6 months post resection

• Skin Graft Failure

  To be assessed at each post skin graft visit for up to 6 months post-resection

Interventions

Synthetic Electrospun Fiber Matrix DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be enrolled in a University Hospital Setting

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acera Surgical, Inc.: lead

Study Sites (1)

University Nevada - Las Vegas

Las Vegas, Nevada, 89102, United States

RECRUITING

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Matthew MacEwan, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 29, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)