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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02373566 |
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Date of registration:
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23/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Evaluate the Efficacy of an Acellular Dermal Template for the Treatment of Full Thickness Skin Defects
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Scientific title:
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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 |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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11 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02373566 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Germany
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Netherlands
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Switzerland
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Contacts
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Name:
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Esther Middelkoop, Prof. dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Red Cross Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Full Thickness Skin Defects
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Intervention(s)
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Device: Novomaix dermal substitute in combination with STSG
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Primary Outcome(s)
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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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Secondary Outcome(s)
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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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Epithelialisation (Subjective assessment by experienced observer)
[Time Frame: 5-7 days and 2-3 weeks post-operative]
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Graft take (Subjective assessment by experienced observer)
[Time Frame: 5-7 days]
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Scar quality (As determined with subjective scar assessment scale (POSAS)
[Time Frame: 3 and 12 months]
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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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Secondary ID(s)
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ESG-NVM-II-2014
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NL50542.094.14
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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