NCT02145130CompletedPhase 1
A Phase I, Two Armed, Open, Prospective and Multicentre Study to Evaluate the Safety of Autologous Tissue-engineered Dermal Substitutes and Dermo-epidermal Skin Substitutes for the Treatment of Large Deep Partial and Full Thickness Skin Defects in Children and Adults
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Zurich
- Enrollment
- 12
- Locations
- 4
- Primary Endpoint
- Safety
Study Overview
Brief Summary
The purpose of this study is the evaluation of the safety of autologous tissue-engineered dermal substitutes "denovoDerm" (first arm) and dermo-epidermal skin substitutes "denovoSkin" (second arm) transplanted onto the wound bed in children and adults.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Deep partial or full thickness skin defect of at least 9 cm2 requiring surgical wound coverage due to:
- •Acute cases: burn injury, soft tissue injury, skin necrosis after purpura fulminans
- •Reconstructive cases (elective surgery): scar formation after burn injuries, congenital giant nevus, skin tumours
- •Informed consent by patients/parents or other legal representatives
Exclusion Criteria
- •Infected wounds or positive general microbiological swabs taken from the nose for multi-resistant germs
- •Patients tested positive for HBV, HCV, syphilis or HIV
- •Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, systemic skin diseases, any kind of congenital defect of metabolism including diabetes)
- •Coagulation disorders as defined by INR outside its normal value, PTT >ULN and fibrinogen <LLN and / or at the Investigator's discretion
- •Previous enrolment of the patient into the current study
- •Participation of the patient in another study within 30 days preceding and during the present study
- •Patients or parents/other legal representatives expected not to comply with the study protocol
- •Suspicion of child abuse
- •Pregnant or breast feeding females
- •Contamination derived from biopsy which could interfere with patients health
- •Due to patient derived variations, isolated cells from biopsy do not proliferate or proliferate insufficiently
- •Skin substitute has not been released due to production specific deviations
- •Patients allergic to amphotericin B and gentamicin
Outcomes
Primary Outcomes
Safety
Time Frame: denovoDerm: 4-6 days and 21 days after transplantation, denovoSkin 9-11 days and 21 days after transplantation
Assessment/reporting of local infection rate and graft take
Secondary Outcomes
- Adverse events(until 90 days post transplantation)
Investigators
Study Sites (4)
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