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

Scars Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02145130
• Other study ID #: EuroSkinGraft / ESG-01-2011
• Status: Completed
• Phase: Phase 1
• Start date: May 2014
• Est. completion date: March 2021

Study information

• Verified date: September 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn Injury
• Congenital Giant Nevus
• Necrosis
• Scars
• Skin Necrosis
• Skin Tumors
• Soft Tissue Injuries
• Soft Tissue Injury
• Wounds and Injuries

Intervention

Biological:
• denovoDerm
Transplantation of an autologous tissue-engineered dermal substitute, covered with autologous split-thickness skin
• denovoSkin
Transplantation of autologous tissue-engineered dermo-epidermal skin substitute, no additional coverage needed

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Zurich: denovoDerm	Zurich	ZH
Switzerland	University Children's Hospital Zurich: denovoSkin	Zurich	ZH

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	University Hospital, Zürich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Assessment/reporting of local infection rate and graft take	denovoDerm: 4-6 days and 21 days after transplantation, denovoSkin 9-11 days and 21 days after transplantation
Secondary	Adverse events	Assessment/reporting of number of adverse events	until 90 days post transplantation