- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02164760
The Safety of a Novel Acellular Dermal Template as Treatment for Burns and Scars
February 13, 2020 updated by: Association of Dutch Burn Centres
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.
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.
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.
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
Interventional
Enrollment (Actual)
13
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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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
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Age ≥18 years
- with acute burns/trauma wounds that require skin grafting (group 1) OR
- 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
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 |
---|---|---|
Graft take (experimental vs control area)
Time Frame: 5-7 days postoperative
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Subjective assessment of two experienced observers
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5-7 days postoperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Epithelialization
Time Frame: 5-7 and 18 ± 2 days days postoperative
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Subjective assessment of two experienced observers
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5-7 and 18 ± 2 days days postoperative
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Complication rate
Time Frame: Up to 12 months postoperative
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Measurement of re-operations, infection rate by culture swabs
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Up to 12 months postoperative
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Scar quality
Time Frame: 3 months
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As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale
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3 months
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Scar quality
Time Frame: 6 months
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As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale
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6 months
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Scar quality
Time Frame: 9 months
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As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale
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9 months
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Scar quality
Time Frame: 12 months
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As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale
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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.
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
June 1, 2013
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
June 11, 2014
First Submitted That Met QC Criteria
June 13, 2014
First Posted (Estimate)
June 17, 2014
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-09-2012
- NL42113.094.12 (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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