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Recruiting NCT06578650

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

— Observational Surgical Wound

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Synthetic Electrospun Fiber Matrix.
Who it may be relevant to
Registry conditions: Surgical Wound. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Synthetic 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

Primary outcome measures

  • Time to wound bed granulation [Time frame: Weekly assessments until granulation achieved or up to 6 weeks following resection surgery]
Secondary outcome measures (5)
  • Time to complete wound healing [Time frame: Until healed or until 16 weeks post resection]
  • Patient pain [Time frame: Weekly for up to six weeks post resection]
  • Time to skin grafting [Time frame: Weekly for up to 6 weeks post-resection]
  • Skin graft "take" rate [Time frame: 1 week after skin graft application]
  • Tissue flap take rate [Time frame: 1 week after tissue flap procedure]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University Nevada - Las Vegas — Las Vegas

Identifiers

NCT: NCT06578650 · 24-RES-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗