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

Primary Purpose

Burn Injury, Soft Tissue Injury, Skin Necrosis

Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
denovoDerm
denovoSkin
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn Injury focused on measuring Skin, Tissue-engineering, Autologous, Dermis, Epidermis

Eligibility Criteria

1 Year - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Children's Hospital Zurich: denovoDerm
  • University Children's Hospital Zurich: denovoSkin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

denovoDerm

denovoSkin

Arm Description

Autologous tissue-engineered dermal substitute

Autologous tissue-engineered dermo-epidermal skin substitute

Outcomes

Primary Outcome Measures

Safety
Assessment/reporting of local infection rate and graft take

Secondary Outcome Measures

Adverse events
Assessment/reporting of number of adverse events

Full Information

First Posted
May 20, 2014
Last Updated
September 6, 2021
Sponsor
University of Zurich
Collaborators
University Hospital, Zürich
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1. Study Identification

Unique Protocol Identification Number
NCT02145130
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
March 2021 (Actual)
Study Completion Date
March 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
University Hospital, Zürich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Injury, Soft Tissue Injury, Skin Necrosis, Scars, Congenital Giant Nevus, Skin Tumors
Keywords
Skin, Tissue-engineering, Autologous, Dermis, Epidermis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
denovoDerm
Arm Type
Experimental
Arm Description
Autologous tissue-engineered dermal substitute
Arm Title
denovoSkin
Arm Type
Experimental
Arm Description
Autologous tissue-engineered dermo-epidermal skin substitute
Intervention Type
Biological
Intervention Name(s)
denovoDerm
Intervention Description
Transplantation of an autologous tissue-engineered dermal substitute, covered with autologous split-thickness skin
Intervention Type
Biological
Intervention Name(s)
denovoSkin
Intervention Description
Transplantation of autologous tissue-engineered dermo-epidermal skin substitute, no additional coverage needed
Primary Outcome Measure Information:
Title
Safety
Description
Assessment/reporting of local infection rate and graft take
Time Frame
denovoDerm: 4-6 days and 21 days after transplantation, denovoSkin 9-11 days and 21 days after transplantation
Secondary Outcome Measure Information:
Title
Adverse events
Description
Assessment/reporting of number of adverse events
Time Frame
until 90 days post transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie Böttcher, PD Dr. med.
Organizational Affiliation
University Children's Hospital, Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Children's Hospital Zurich: denovoDerm
City
Zurich
State/Province
ZH
ZIP/Postal Code
8032
Country
Switzerland
Facility Name
University Children's Hospital Zurich: denovoSkin
City
Zurich
State/Province
ZH
ZIP/Postal Code
8032
Country
Switzerland

12. IPD Sharing Statement

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

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