Phase I Study for Autologous Dermal Substitutes and Dermo-epidermal Skin Substitutes for Treatment of Skin Defects

University of Zurich (UZH)

Status and phase

Completed

Phase 1

Conditions

Scars

Skin Tumors

Soft Tissue Injury

Burn Injury

Skin Necrosis

Congenital Giant Nevus

Treatments

Biological: denovoDerm

Biological: denovoSkin

Study type

Interventional

Funder types

Other

Identifiers

NCT02145130

EuroSkinGraft / ESG-01-2011

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

1 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Deep partial or full thickness skin defect of at least 9 cm2 requiring surgical wound coverage due to:
1. Acute cases: burn injury, soft tissue injury, skin necrosis after purpura fulminans
2. 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