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Randomized Controlled Trial
. 2013 Dec 19:14:439.
doi: 10.1186/1745-6215-14-439.

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

Eveline Bijlard  1 , Reinier Timman, Gerda M Verduijn, Frank B Niessen, Johan W van Neck, Jan J V Busschbach, Marc A M Mureau
Affiliations
Randomized Controlled Trial

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

Eveline Bijlard et al. Trials. .

Abstract

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.

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References

    1. Niessen FB, Spauwen PH, Schalkwijk J, Kon M. On the nature of hypertrophic scars and keloids: a review. Plast Reconstr Surg. 1999;14:1435–1458. doi: 10.1097/00006534-199910000-00031. - DOI - PubMed
    1. Brown BC, McKenna SP, Siddhi K, McGrouther DA, Bayat A. The hidden cost of skin scars: quality of life after skin scarring. J Plast Reconstr Aesthet Surg. 2008;14:1049–1058. doi: 10.1016/j.bjps.2008.03.020. - DOI - PubMed
    1. Cohen IK, Beaven MA, Horáková Z, Keizer HR. Histamine and collagen synthesis in keloid and hypertrophic scar. Surg Forum. 1972;14:509–510. - PubMed
    1. Cohen IK, Keizer HR, Sjoerdsma A. Collagen synthesis in human keloid and hypertrophic scar. Surg Forum. 1971;14:488–489. - PubMed
    1. Syed F, Ahmadi E, Iqbal SA, Singh S, McGrouther DA, Bayat A. Fibroblasts from the growing margin of keloid scars produce higher levels of collagen I and III compared with intralesional and extralesional sites: clinical implications for lesional site-directed therapy. Br J Dermatol. 2011;14:83–96. doi: 10.1111/j.1365-2133.2010.10048.x. - DOI - PubMed

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