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

Trials
Eveline BijlardMarc A M Mureau

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. 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 analys...Continue Reading

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Citations

Aug 28, 2014·Plastic and Reconstructive Surgery·Michiel C E van LeeuwenFrank B Niessen
Sep 27, 2014·Journal of Plastic, Reconstructive & Aesthetic Surgery : JPRAS·Michiel C E van LeeuwenFrank B Niessen
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Jan 30, 2015·Plastic and Reconstructive Surgery·Michiel C E van LeeuwenFrank B Niessen
Dec 1, 2017·International Journal of Molecular Sciences·Tae Hwan ParkKyung-Soon Park

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Software Mentioned

SAS
POSAS
SPSS
MinimPy

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