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Surgical and aesthetic outcome, quality of life, and cost-effectiveness of keloid treatment


- candidate number15296
- NTR NumberNTR4151
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-aug-2013
- Secondary IDsNL40235.078.12 Toetsingonline CCMO
- Public TitleSurgical and aesthetic outcome, quality of life, and cost-effectiveness of keloid treatment
- Scientific TitleSurgical and aesthetic outcome, quality of life, and cost-effectiveness of keloid treatment
- ACRONYM
- hypothesisIntralesional cryotherapy for keloid treatment is better than excision with either corticosteroid injections or brachytherapy post-operative.
- Healt Condition(s) or Problem(s) studiedKeloid
- Inclusion criteriaKeloid patients, 1-3 keloids, keloid >1x1 cm, 18-75 yr old, full mental competence, sufficient knowledge of Dutch or English language, keloid suitable for primary closure after excision.
- Exclusion criteriaHypertrophic scars, keloids < 1yr old, burn scars, pregnancy, use of chemotherapy, chronic use of corticosteroids or immonosuppressors, life expectancy < 1 yr, hypersensitivity for lidocaine, epinephrine, triamcenolone acetonide
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2012
- planned closingdate1-dec-2015
- Target number of participants26
- InterventionsPrimary keloids: intralesional cryotherapy or extralesional excision with adjuvant triamcenolonacetonide 40mg/ml injections starting 2 weeks post operative. Resistant keloids: intralesional cryotherapie or extralesional excision with adjuvant Ir-192 brachy therapy 12-18Gy in 2 or 3 fractions within the first 2 post operative days.
- Primary outcomePatient Observer Scar Assessment Scals score.
- Secondary outcomevolume reduction, Skindex-29, SF-36, ED-5Q, histology, appearance of adverse reactions.
- Timepointsbaseline, and 2, 12, 26 and 52 weeks postoperatively
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMs Eveline Bijlard
- CONTACT for SCIENTIFIC QUERIESMs Eveline Bijlard
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Fonds Nuts-Ohra
- PublicationsN/A
- Brief summaryThis is a multicentre randomised controlled open trial that compares surgical keloid treatments with validated PROMs as outcome measures. The outcomes of this study will improve evidence-based decision-making for the treatment of keloids, as well as patient education.
- Main changes (audit trail)11-nov-2015:
Inclusion NEW:
Keloid patients, keloid >1x1 cm, 18-75 yr old, full mental competence, sufficient knowledge of Dutch or English language, keloid suitable for primary closure after excision.

Secondairy outcome NEW:
volume reduction, Skindex-29, SF-36, ED-5Q, appearance of adverse reactions, patient statisfaction.
- RECORD21-aug-2013 - 11-nov-2015


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