Phase
Condition
Pressure Ulcer
Neoplasms
Skin Cancer
Treatment
Synthetic Electrospun Fiber Matrix
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 writteninformed consent prior to participation in study
Post-resection surgical wound with a surface area of ≥4 cm2 and ≤ 36cm2
Exclusion
Exclusion Criteria:
Inability to give informed consent or to complete the procedures required for studycompletion
Patient has been previously enrolled into this study, or is currently participatingin 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 pastfour 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 historyof 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 anestimated glomerular filtration rate less than 15mL/min
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
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 connectivetissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoidarthritis
Active infection, undrained abscess, or critical colonization of the wound withbacteria in the judgement of the investigator
Study Design
Connect with a study center
University Nevada - Las Vegas
Las Vegas, Nevada 89102
United StatesActive - Recruiting
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