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The Safety of a Novel Acellular Dermal Template as Treatment for Burns and Scars

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02164760
Recruitment Status : Unknown
Verified June 2015 by Association of Dutch Burn Centres.
Recruitment status was:  Active, not recruiting
First Posted : June 17, 2014
Last Update Posted : June 26, 2015
Sponsor:
Collaborators:
Ernst Reichmann Tissue Biology Research Unit, Zürich
Seventh Framework Programme
Information provided by (Responsible Party):
Association of Dutch Burn Centres

Tracking Information
First Submitted Date  ICMJE June 11, 2014
First Posted Date  ICMJE June 17, 2014
Last Update Posted Date June 26, 2015
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2014)
Graft take (experimental vs control area) [ Time Frame: 5-7 days postoperative ]
Subjective assessment of two experienced observers
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02164760 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2014)
  • Epithelialization [ Time Frame: 5-7 and 18 ± 2 days days postoperative ]
    Subjective assessment of two experienced observers
  • Complication rate [ Time Frame: Up to 12 months postoperative ]
    Measurement of re-operations, infection rate by culture swabs
  • Scar quality [ Time Frame: 3 months ]
    As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale
  • Scar quality [ Time Frame: 6 months ]
    As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale
  • Scar quality [ Time Frame: 9 months ]
    As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale
  • Scar quality [ Time Frame: 12 months ]
    As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Safety of a Novel Acellular Dermal Template as Treatment for Burns and Scars
Official Title  ICMJE A Phase 1, Randomized, Multicentre Multinational Study to Evaluate the Safety and Feasibility of an Acellular Dermal Template Novomaix for the Treatment of Full Thickness Skin Defects in Human Patients.
Brief Summary In this study the safety and feasibility of an acellular dermal template (Novomaix), combined with split thickness skin grafts, for use in patients with full thickness skin defects, is tested. Results will be compared intra-patient with those obtained after conventional treatment with split thickness skin grafts. We expect this treatment to be safe, and to provide better outcome regarding scar quality.
Detailed Description Using dermal substitutes in combination with a split-thickness skin graft (STSG) is a well acknowledged therapy in burns and reconstructive surgery. Nevertheless, the ideal substitute is not available yet. We therefore want to investigate the use of an acellular dermal template (Novomaix), in combination with STSG, to treat these defects. Adult patients with acute (burn) wounds (group 1) and scars (group 2) will be included in this study. This phase I study aims to investigate the safety and feasibility of the use of this dermal matrix, with regard to graft take, epithelialisation and complications after transplantation. Moreover, scar quality will be evaluated.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Full Thickness Skin Defects
Intervention  ICMJE Device: Novomaix dermal substitute in combination with STSG
Novomaix dermal substitute in combination with STSG
Other Name: Novomaix
Study Arms  ICMJE
  • Experimental: Dermal substitute with STSG
    Novomaix dermal substitute in combination with STSG
    Intervention: Device: Novomaix dermal substitute in combination with STSG
  • No Intervention: STSG alone
    STSG alone
Publications * Boekema BK, Vlig M, Olde Damink L, Middelkoop E, Eummelen L, Bühren AV, Ulrich MM. Effect of pore size and cross-linking of a novel collagen-elastin dermal substitute on wound healing. J Mater Sci Mater Med. 2014 Feb;25(2):423-33. doi: 10.1007/s10856-013-5075-2. Epub 2013 Nov 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 13, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2016
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥18 years

    1. with acute burns/trauma wounds that require skin grafting (group 1) OR
    2. with scar problems requiring surgical treatment (group 2)
  • Full thickness skin defects of 50 cm2 or more, but <50% TBSA
  • Skin defects must be configured in such a way that two areas of 25 cm2 can be grafted
  • Informed consent by the patient

Exclusion Criteria:

  • Patients with infected wounds
  • Pregnant or breast feeding females
  • Patients with known concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, HIV, diabetes, collagenoses, cancer)
  • Known allergy against porcine collagen or elastin
  • Patients who are expected (according to the responsible medical doctor) to be noncompliant to the study protocol. (This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
  • Previous enrolment of the patient into the current study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02164760
Other Study ID Numbers  ICMJE ESG-09-2012
NL42113.094.12 ( Other Identifier: ABR )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Association of Dutch Burn Centres
Study Sponsor  ICMJE Association of Dutch Burn Centres
Collaborators  ICMJE
  • Ernst Reichmann Tissue Biology Research Unit, Zürich
  • Seventh Framework Programme
Investigators  ICMJE
Principal Investigator: Esther Middelkoop, Prof. dr. Red Cross Hospital
PRS Account Association of Dutch Burn Centres
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP