Intralesional cryotherapy versus excision and corticosteroids or brachytherapy for keloid treatment: study protocol for a randomised controlled trial.

Trials (Impact Factor: 2.21). 12/2013; 14(1):439. DOI: 10.1186/1745-6215-14-439
Source: PubMed

ABSTRACT Keloids are a burden for patients due to physical, aesthetic and social complaints and treatment remains a challenge because of therapy resistance and high recurrence rates. The main goal of treatment is to improve the quality of life (QoL); this implies that, apart from surgical outcomes, patient-reported outcome measures (PROMs) need to be taken into account. Decision making in keloid treatment is difficult due to heterogeneity of the condition and the lack of comparative studies.Methods/design: This is a multicentre, randomised controlled open trial that compares 1) intralesional cryotherapy versus excision and corticosteroids for primary keloids, and 2) intralesional cryotherapy versus excision and brachytherapy for therapy-resistant keloids. The primary outcome is the Patient and Observer Scar Assessment Scale (POSAS), a 12-item scale (with score 12 indicating the best and 120 indicating the worst scar imaginable). A difference of six points on the total score is considered to be of clinical importance. Secondary outcomes are recurrence rates, volume reduction, Skindex-29 scores, SF-36 scores and complication rates. Primary and secondary outcome measurements are taken at baseline, and at 2, 12, 26 and 52 weeks postoperatively. For analysis, a linear mixed model is used. A total of 176 patients will be included over a period of 2.5 years. The protocol is approved by the Medical Ethics Committee of the Erasmus University Medical Centre Rotterdam and follows good clinical practice guidelines.
The outcomes of this study will improve evidence-based decision making for the treatment of keloids, as well as patient education.Trial registration: Dutch Trial Register NTR4151.

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    ABSTRACT: No universally accepted standard for evaluation, prevention, and treatment of scars, hypertrophic scars, and keloids exists. Following development of a questionnaire, we performed a closed Web-based survey among burn centers. Server-based data collection was performed over 4 weeks and closed thereafter.The poll revealed emerging new treatment schemes, but the majority of participants adhered to evaluation (Patient and Observer Scar Assessment Scale, Matching Assessment of Scars and Photographs, Vancouver Scar Scale, two-dimensional photography) and prevention (silicone gel sheets and compression garments) strategies that were in line with the currently available recommendations from the literature. We noted a low penetration for the use of objective evaluation tools in our poll and detected differences in surgical approaches to keloids.Based on the results of our survey and the power of currently available clinical recommendations, we expect future guidelines to gain more evidence-based power, especially when more high-quality clinical trials with objective evaluation support, clearly defined disease entities, and therapeutic outcome factors have become available.
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