- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02373566
A Study to Evaluate the Efficacy of an Acellular Dermal Template for the Treatment of Full Thickness Skin Defects
February 13, 2020 updated by: Association of Dutch Burn Centres
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany, 12683
- Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie
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Noord-Holland
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Beverwijk, Noord-Holland, Netherlands, 1942 LE
- Red Cross Hospital
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Zurich, Switzerland
- Children's Hospital Department of Surgery Kinderspital Zurich
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Dermal substitute with STSG
Novomaix dermal substitute in combination with STSG
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Novomaix dermal substitute in combination with STSG
Other Names:
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No Intervention: STSG alone
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Scar elasticity as measured by Cutometer or as assessed using subjective scar assessment scale (POSAS)
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3 months post-operative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Graft take (Subjective assessment by experienced observer)
Time Frame: 5-7 days
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5-7 days
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Epithelialisation (Subjective assessment by experienced observer)
Time Frame: 5-7 days and 2-3 weeks post-operative
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Subjective assessment by experienced observer
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5-7 days and 2-3 weeks post-operative
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Scar quality (Scar elasticity as measured by Cutometer or as assessed using POSAS questionnaire)
Time Frame: 12 months
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Scar elasticity as measured by Cutometer or as assessed using POSAS questionnaire
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12 months
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Scar quality (As determined with subjective scar assessment scale (POSAS)
Time Frame: 3 and 12 months
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As determined with subjective scar assessment scale (POSAS)
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3 and 12 months
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Scar quality (As measured for scar colour and pigmentation using DSM II ColorMeter)
Time Frame: 3 and 12 months
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As measured for scar colour and pigmentation using DSM II ColorMeter
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3 and 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Esther Middelkoop, Prof. dr., Red Cross Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
February 23, 2015
First Submitted That Met QC Criteria
February 26, 2015
First Posted (Estimate)
February 27, 2015
Study Record Updates
Last Update Posted (Actual)
February 17, 2020
Last Update Submitted That Met QC Criteria
February 13, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- ESG-NVM-II-2014
- NL50542.094.14 (Other Identifier: ABR)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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