Status:
ACTIVE_NOT_RECRUITING
Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Full-Thickness Skin Defects in Adults and Children
Lead Sponsor:
CUTISS AG
Collaborating Sponsors:
Wyss Zurich
Julius Clinical
Conditions:
Skin Wound
Eligibility:
All Genders
1+ years
Phase:
PHASE2
Brief Summary
This phase II trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and children with full-thickness Skin defects.
Detailed Description
This multicentre phase II clinical trial will target adults and children with fullt-thickness skin defects to elucidate the benefit of a tissue-engineered autologous skin substitute. Particular emphas...
Eligibility Criteria
Inclusion
- Age: ≥1 years of age
- Large full-thickness defects that require coverage after excision of: Scars, Benign skin tumors (e.g. neurofibroma), Melanocytic nevus (e.g. giant nevus), Gender reassignment surgery, Soft tissue defect after trauma, Soft tissue defect after infection and debridement (e.g necrotizingn fascitis, hidadentitis suppurativa, purpura fulminans), Flap donorsite (e.g. radial forearm flap)
- Minimal areas requiring coverage (not counting the head and neck area for study patients in The Netherlands): 1-5 years: minimum 9cm2, 6-16 years: minimum 25cm2, \>16 years: minimum 45cm2
- Signed Informed consent
Exclusion
- 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. systemic skin and connective tissue diseases, any kind of congenital defect of metabolism including insulin-dependent diabetes mellitus, Cushing syndrome or disease, scurvy, chronic hypothyroidism, congenital or acquired immunosuppressive condition, chronic renal failure, or chronic hepatic dysfunction (Child-Pugh class B or C), severe malnutrition, or other concomitant illness which, in the opinion of the Investigator, has the potential to significantly delay wound healing)
- Severe drug and alcohol abuse
- Pre-existing coagulation disorders as defined by INR outside its normal value, PTT \>ULN and fibrinogen \<LLN prior to the current hospital admission and / or at the Investigator's discretion
- Patients with known allergies to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen
- Previous enrolment of the patient into the current phase II study
- Participation of the patient in another study with conflicting endpoints within 30 days preceding and during the present study
- Patients expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
- Pregnant or breast feeding females
- Intention to become pregnant during the clinical course of the study (12 months)
- Enrolment of the Investigator, his/her family members, employees and other dependent persons
Key Trial Info
Start Date :
February 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03394612
Start Date
February 14 2018
End Date
December 1 2026
Last Update
February 24 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Chirurgia Plastica e Centro Ustioni Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli
Napoli, Italy
2
Unità di Chirurgia Plastica e Ustioni Ospedale Santobono
Napoli, Italy
3
U.O.C. Grandi Ustionati Azienda Ospedale Università Padova
Padua, Italy
4
Dept. of Plastic, Reconstructive and Hand Surgery, VU University Medical Center
Amsterdam, Netherlands, 1081