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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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ClinicalTrials.gov Identifier: NCT02145130
Recruitment Status : Recruiting
First Posted : May 22, 2014
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Burn Injury Soft Tissue Injury Skin Necrosis Scars Congenital Giant Nevus Skin Tumors Biological: denovoDerm Biological: denovoSkin Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2014
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : January 2023

Arm Intervention/treatment
Experimental: denovoDerm
Autologous tissue-engineered dermal substitute
Biological: denovoDerm
Transplantation of an autologous tissue-engineered dermal substitute, covered with autologous split-thickness skin

Experimental: denovoSkin
Autologous tissue-engineered dermo-epidermal skin substitute
Biological: denovoSkin
Transplantation of autologous tissue-engineered dermo-epidermal skin substitute, no additional coverage needed




Primary Outcome Measures :
  1. Safety [ Time Frame: denovoDerm: 4-6 days and 21 days after transplantation, denovoSkin 9-11 days and 21 days after transplantation ]
    Assessment/reporting of local infection rate and graft take


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: until 90 days post transplantation ]
    Assessment/reporting of number of adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02145130


Contacts
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Contact: Ernst Reichmann, Prof +41 44 634 89 11

Locations
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Netherlands
Dept. of Plastic, Reconstructive and Hand Surgery, VU University Medical Center Not yet recruiting
Amsterdam, Netherlands, 1081
Brandwondencentrum, Rode Kruis Ziekenhuis Not yet recruiting
Beverwijk, Netherlands, 1940
Switzerland
University Children's Hospital Zurich: denovoDerm Recruiting
Zurich, ZH, Switzerland, 8032
University Children's Hospital Zurich: denovoSkin Completed
Zurich, ZH, Switzerland, 8032
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Martin Meuli, Prof University Children's Hospital, Zurich

Additional Information:
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02145130     History of Changes
Other Study ID Numbers: EuroSkinGraft / ESG-01-2011
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018

Keywords provided by University of Zurich:
Skin
Tissue-engineering
Autologous
Dermis
Epidermis

Additional relevant MeSH terms:
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Wounds and Injuries
Necrosis
Burns
Soft Tissue Injuries
Pathologic Processes