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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01409759 |
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Date of registration:
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03/08/2011 |
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Primary sponsor: |
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Public title:
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Perforator Based Interposition Plasty
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Scientific title:
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Perforator Based Interposition Flaps for Sustainable Release of Burn Scar Contracture: a Reliable, Simple and Versatile Technique. A Randomised Controlled Trial. |
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Date of first enrolment:
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July 2011 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01409759 |
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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, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Carlijn Stekelenburg, MD |
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Address:
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Telephone:
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0031251265459 |
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Email:
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cstekelenburg@rkz.nl |
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Affiliation:
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Name:
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Paul P M Van Zuijlen, Prof |
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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:
- Indication for release of burn scar contracture
- Sufficient tissue for a perforator- based interposition flap (preferably normal skin)
- Able to give informed consent
Exclusion Criteria:
- Age < 18 years
- Location: scars on the face and scalp
- Smoking (however, the patient is eligible if smoking is quit > 3 weeks before the
operation)
- Psychiatric disorders (if a loss to follow-up is anticipated)
- Language barrier
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Burn Scar Contraction
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Intervention(s)
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Procedure: Perforator based interposition flap
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Primary Outcome(s)
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Expansion/contraction of the interpositioned skin after 3 months
[Time Frame: 3 months]
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Secondary ID(s)
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10104 and 10110
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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