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A Study to Evaluate the Efficacy of an Acellular Dermal Template for the Treatment of Full Thickness Skin Defects

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: NCT02373566
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
Ernst Reichmann Tissue Biology Research Unit, Zürich
Seventh Framework Programme
Information provided by (Responsible Party):
Association of Dutch Burn Centres

Brief Summary:
In this study the efficacy 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. The investigators expect this treatment to provide better outcome regarding scar quality.

Condition or disease Intervention/treatment Phase
Full Thickness Skin Defects Device: Novomaix dermal substitute in combination with STSG Not Applicable

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. Patients with with full thickness skin defects will be included in this study. This phase II study aims to investigate the efficacy of the use of this dermal matrix, with regard to scar quality as determined for elasticity at 3 months after treatment. Moreover, graft take (5-7 days after treatment), epithelialisation (5-7 days and 2-3 weeks), and scar quality (3 and 12 months after treatment, as determined for elasticity, colour/pigmentation, and using a subjective scar assessment scale) will be evaluated.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: part of wound treated with /without dermal template
Masking: Double (Participant, Outcomes Assessor)
Masking Description: participant and assessor are both unaware of location of dermal template
Primary Purpose: Treatment
Official Title: A Phase 2, Intra-patient Randomised Controlled Multicentre International Study to Evaluate the Efficacy of an Acellular Dermal Template Novomaix for the Treatment of Full Thickness Skin Defects
Study Start Date : February 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: Dermal substitute with STSG
Novomaix dermal substitute in combination with STSG
Device: Novomaix dermal substitute in combination with STSG
Novomaix dermal substitute in combination with STSG
Other Name: Novomaix

No Intervention: STSG alone
STSG alone



Primary Outcome Measures :
  1. Scar quality as assessed for scar elasticity (experimental vs control area) as measured by Cutometer or as assessed using subjective scar assessment scale (POSAS) [ Time Frame: 3 months post-operative ]
    Scar elasticity as measured by Cutometer or as assessed using subjective scar assessment scale (POSAS)


Secondary Outcome Measures :
  1. Graft take (Subjective assessment by experienced observer) [ Time Frame: 5-7 days ]
  2. Epithelialisation (Subjective assessment by experienced observer) [ Time Frame: 5-7 days and 2-3 weeks post-operative ]
    Subjective assessment by experienced observer

  3. Scar quality (Scar elasticity as measured by Cutometer or as assessed using POSAS questionnaire) [ Time Frame: 12 months ]
    Scar elasticity as measured by Cutometer or as assessed using POSAS questionnaire

  4. Scar quality (As determined with subjective scar assessment scale (POSAS) [ Time Frame: 3 and 12 months ]
    As determined with subjective scar assessment scale (POSAS)

  5. Scar quality (As measured for scar colour and pigmentation using DSM II ColorMeter) [ Time Frame: 3 and 12 months ]
    As measured for scar colour and pigmentation using DSM II ColorMeter



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years (for Zurich: ≤ 18 years)
  • Full thickness skin defects configured in such a way that two comparable and measurable areas can be grafted, both of minimally 3x3 cm
  • ≤ 50% TBSA full thickness skin defects at time of intervention
  • Informed consent by the patient and/or legal representatives.

Exclusion Criteria:

  • Patients with infected wounds
  • Full thickness skin wounds located in face and/or genitals will not be included
  • Pregnant or breast feeding females
  • Patients with known concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, HIV, uncontrolled diabetes, treatment with corticoid therapy, collagenoses, cancer)
  • Known allergy against porcine collagen or elastin
  • Patients that are expected (according to the responsible medical doctor) to be non-compliant 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

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): NCT02373566


Locations
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Germany
Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie
Berlin, Germany, 12683
Netherlands
Red Cross Hospital
Beverwijk, Noord-Holland, Netherlands, 1942 LE
Switzerland
Children's Hospital Department of Surgery Kinderspital Zurich
Zurich, Switzerland
Sponsors and Collaborators
Association of Dutch Burn Centres
Ernst Reichmann Tissue Biology Research Unit, Zürich
Seventh Framework Programme
Investigators
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Principal Investigator: Esther Middelkoop, Prof. dr. Red Cross Hospital
Additional Information:
Publications:
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Responsible Party: Association of Dutch Burn Centres
ClinicalTrials.gov Identifier: NCT02373566    
Other Study ID Numbers: ESG-NVM-II-2014
NL50542.094.14 ( Other Identifier: ABR )
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Keywords provided by Association of Dutch Burn Centres:
burns
dermal substitute
scar quality
reconstruction
wound healing
wound closure