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

Last updated: May 27, 2025
Sponsor: Acera Surgical, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pressure Ulcer

Neoplasms

Skin Cancer

Treatment

Synthetic Electrospun Fiber Matrix

Clinical Study ID

NCT06578650
24-RES-002
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 writteninformed consent prior to participation in study

  5. Post-resection surgical wound with a surface area of ≥4 cm2 and ≤ 36cm2

Exclusion

Exclusion Criteria:

  1. Inability to give informed consent or to complete the procedures required for studycompletion

  2. Patient has been previously enrolled into this study, or is currently participatingin 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 pastfour 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 historyof 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 anestimated glomerular filtration rate less than 15mL/min

  16. Patients with severe liver disease with active cirrhosis defined as a gross ascitesupon clinical exam or a Model for End-stage Liver Disease (MELD)-Na score greaterthan 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 connectivetissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoidarthritis

  21. Active infection, undrained abscess, or critical colonization of the wound withbacteria in the judgement of the investigator

Study Design

Total Participants: 34
Treatment Group(s): 1
Primary Treatment: Synthetic Electrospun Fiber Matrix
Phase:
Study Start date:
October 31, 2024
Estimated Completion Date:
May 31, 2027

Connect with a study center

  • University Nevada - Las Vegas

    Las Vegas, Nevada 89102
    United States

    Active - Recruiting

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