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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgical Wound
• Intervention / Treatment: Device: Synthetic Electrospun Fiber Matrix

• Study Type: Observational
• Enrollment (Estimated): 34

Contacts and Locations

• Study Contact: Name: Matthew MacEwan, PhD; Phone Number: 440-477-1890; Email: macewan@acera-surgical.com

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Recruiting
      • University Nevada - Las Vegas
      • Contact: Michelle Tomasino, CHPSE; Phone Number: 702-895-4923; Email: michelle.tomasino@unlv.edu
      • Principal Investigator: Brian Ward, MD, PhD, FACS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will be enrolled in a University Hospital Setting

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to complete wound healing	Total healing time will be documented (in days) at the final follow-up appointment by calculating the difference using the resection visit and "healed" visit dates.	Until healed or until 16 weeks post resection
Patient pain	Pain reported by patient on a Visual Analogue Scale (VAS), with 0 indicating no pain and 10 indicating worst pain possible. Lower scores are indicative of a better outcome	Weekly for up to six weeks post resection
Time to skin grafting	Time from resection and product place until skin grafting (if patient elects to do so)	Weekly for up to 6 weeks post-resection
Skin graft "take" rate	Percent of skin graft incorporation as assessed by the investigator, in patients who elect to undergo skin grafting	1 week after skin graft application
Tissue flap take rate	Percent of successful tissue graft incorporation as assessed by the investigator, in patients who elect to undergo tissue flap procedures	1 week after tissue flap procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar quality	Scar quality using a Vancouver Scar Scale (VSS). The scale ranges from 0 (normal skin) to 13 (worst scar outcome). Lower scores are indicative of a better scar outcome	At the time of complete wound closure and at the 6 month post-resection follow up
Infection rate and severity	Incidence and severity of wound bed infection (if one occurs) per CTCAE V5.0 definitions ranging from 1 (localized, local intervention indicated) to 5 (death). Lower scores are indicative of milder infections	to be assessed at each visit for up to 6 months post resection
Skin Graft Failure	Incidence of inadequate skin graft adherence to the underlying wound bed as assessed by the investigator in patients who have received a skin graft	To be assessed at each post skin graft visit for up to 6 months post-resection
Tissue flap failure	Incidence of complete flap necrosis or need for total flap removal in patients who receive a tissue flap	Each post-flap follow up visit for up to 6 months post-resection
Incidence of local skin cancer recurrence	local recurrence of skin cancer	at the 6 month post-resection follow up

Collaborators and Investigators

• Sponsor: Acera Surgical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Neoplasms by Site; Skin Diseases; Surgical Wound; Neoplasms; Skin Neoplasms
• Other Study ID Numbers: 24-RES-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes