A Pilot Study to Evaluate a Temporary Skin Substitute (Spincare® Matrix) for Wound Healing in RDEB Patients (RDEB)
Recessive Dystrophic Epidermolysis Bullosa
About this trial
This is an interventional treatment trial for Recessive Dystrophic Epidermolysis Bullosa
Eligibility Criteria
Inclusion Criteria: Clinical and genetic diagnosis of RDEB by a dermatologist Age 6 years or older willing and able to give consent/assent At least 6 wounds (3 wound pairs) each with an area of 10cm2 or greater located at any site (excluding face and genital skin) Wounds must be present for at least 4 weeks and able to be classified as recurrent wounds (wounds that heal within 12 weeks but then re-blister) vs chronic open (older than 12 weeks) Exclusion Criteria: Actively infected wounds with pus (colonized wounds are eligible) Wounds that have had squamous cell carcinoma (SCC) Wounds on the face and genitals Wounds that have been treated with investigational therapies in the past 3 months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
control wound
matrix treated wounds
standard of care dressing and bandages
wounds treated with Spincare matrix device at monthly intervals or as required at the discretion of the principal investigator