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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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19 February 2015 |
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Main ID: |
NCT01706861 |
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Date of registration:
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03/10/2012 |
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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 Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid Lesions Treated Adjunctive to Surgical Excision
EURO KLEAR |
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Scientific title:
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A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid LEsions Treated Adjunctive to suRgical Excision. PMCS: EURO-KLEAR |
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Date of first enrolment:
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September 2012 |
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Target sample size:
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51 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01706861 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Bahamas
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Poland
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United Kingdom
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Contacts
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Name:
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Sam Bella, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Westbourne Centre |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients electing to undergo keloid excision procedure
- Patients able and willing to give written informed consent
Exclusion Criteria:
- Patients with a known or potential risk of allergy or sensitivity to products or
substances containing porcine gelatin.
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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Earlobe Keloids
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Intervention(s)
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Device: Celotres
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Primary Outcome(s)
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Recurrence of keloid post scar excision
[Time Frame: Assessed at 1, 3, 6, 9 and 12 months]
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The incidence of device related adverse events
[Time Frame: Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12]
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Secondary Outcome(s)
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Subject Dermatology Life Quality Index (DLQI)
[Time Frame: Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12]
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Patient and Observer Scar Assessment Scale (POSAS)
[Time Frame: Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12]
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Device Performance Evaluation
[Time Frame: Assessed at Day 1]
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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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