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

• Published in: Trials
• Main Authors: Bijlard, E. (Eveline), Timman, R. (Reinier), Verduijn, G.M. (Gerda), Niessen, F.B. (Francisus B.), Neck, J.W. (Han) van, Busschbach, J.J. (Jan) van, Mureau, M.A.M. (Marc)
• Format: Article in Journal/Newspaper
• Language: English
• Published: 2013
• Subjects: Brachytherapy; Corticosteroids; Cryotherapy; Keloid; POSAS; Quality of life; RCT; SF36; Skindex-29; SCAR
• Online Access: http://repub.eur.nl/pub/74527; https://doi.org/10.1186/1745-6215-14-439

Background: 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.Discussion: 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.