Clinical trial NCT02145130: Phase I Study for Autologous Dermal Substitutes and Dermo-epidermal Skin Substitutes for Treatment of Skin Defects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Burn Injury
Soft Tissue Injury
Skin Necrosis
Scars
Congenital Giant Nevus
Skin Tumors
Keywords: Skin
Tissue-engineering
Autologous
Dermis
Epidermis
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University Hospital, Zürich
First posted: 2014-05-22
Enrollment: 12
Sex: ALL
Minimum age (years): 1
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety
timeFrame: denovoDerm: 4-6 days and 21 days after transplantation, denovoSkin 9-11 days and 21 days after transplantation
Secondary outcomes:
measure: Adverse events
timeFrame: until 90 days post transplantation
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Children's Hospital Zurich: denovoDerm
state: ZH
city: Zurich
country: Switzerland
facility: University Children's Hospital Zurich: denovoSkin
state: ZH
Study officials:
affiliation: University Children's Hospital, Zurich
name: Sophie Böttcher, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: