Intralesional cryotherapy versus excision and corticosteroids or brachytherapy for keloid treatment: study protocol for a randomised controlled trial
1 Department of Plastic Reconstructive and Hand Surgery ErasmusMC, Erasmus University Medical Centre Rotterdam Room EE1591 Dr, Molewaterplein, 50 3015 GE, Rotterdam, Netherlands
2 Department of Psychiatry, Section Medical Psychology and Psychotherapy ErasmusMC, Erasmus University Medical Centre Rotterdam’s, Gravendijkwal, 230 3015 CE, Rotterdam, Netherlands
3 Department of Radiation Oncology, ErasmusMC, Erasmus University Medical Centre Rotterdam, Groene Hilledijk, 301 3075 EA, Rotterdam, Netherlands
4 Department of Plastic Reconstructive and Hand Surgery, VU Medical Center, University Medical Centre, Boelelaan 1117, 1081 HV, Amsterdam, Netherlands
Trials 2013, 14:439 doi:10.1186/1745-6215-14-439Published: 19 December 2013
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.
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.
Dutch Trial Register NTR4151.