StrataXRT Versus Mepitel Film for Prevention of Acute Radiation Dermatitis in Postmastectomy Radiotherapy: A Pooled Analysis of Intra-Patient Randomised Trials.
IF 2.1 Q3 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING
Shing Fung Lee, Patries M Herst, Melissa L James, Pui Lam Yip, Carminia Lapuz, Farshad Foroudi, Michael Chao
{"title":"StrataXRT Versus Mepitel Film for Prevention of Acute Radiation Dermatitis in Postmastectomy Radiotherapy: A Pooled Analysis of Intra-Patient Randomised Trials.","authors":"Shing Fung Lee, Patries M Herst, Melissa L James, Pui Lam Yip, Carminia Lapuz, Farshad Foroudi, Michael Chao","doi":"10.1002/jmrs.70117","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>We report a pooled analysis of two multicentre intra-patient randomised controlled trials (RCTs) comparing the silicone-based dressings Mepitel Film and StrataXRT for the prevention of acute radiation dermatitis (ARD) in postmastectomy radiotherapy (RT).</p><p><strong>Methods: </strong>Each irradiated chest wall was divided into medial and lateral halves, randomised to one dressing each. The primary endpoint was the incidence of grade 2 or 3 ARD. Secondary endpoints included grade 3 ARD, moist desquamation, time to moist desquamation, Radiation-Induced Skin Reaction Assessment Scale (RISRAS) scores, adverse events, and treatment preferences. Discordant-pair methods, conditional logistic regression, paired comparisons of area under the curve (AUC), and longitudinal fixed-effects regression were used.</p><p><strong>Results: </strong>A total of 120 patients (median age, 60 years; interquartile range, 51-69) were included (Australia, n = 40; New Zealand, n = 80); 64.2% received moderately hypofractionated or ultrahypofractionated RT. Among 38 discordant pairs, grade 2 or 3 ARD occurred only on the StrataXRT side in 30 patients and only on the Mepitel Film side in eight patients (odds ratio 3.75, 95% CI 1.72-8.18; p = 0.001). Grade 3 ARD and moist desquamation did not differ significantly. HCP-assessed RISRAS AUCs for erythema (p < 0.001) and moist desquamation (p = 0.034) were significantly lower with Mepitel Film, consistent with the longitudinal analyses. Patient-reported RISRAS AUCs did not differ between treatments. Treatment preferences were broadly balanced.</p><p><strong>Conclusions: </strong>Mepitel Film reduced the incidence of grade 2 or 3 ARD and cumulative HCP-assessed erythema and moist desquamation burden compared with StrataXRT, while patient-reported symptom burden was similar. Selection of a prophylactic dressing for postmastectomy RT should consider patient preference, cost, ease of application, skin sensitivity, and available resources.</p><p><strong>Trial registration: </strong>Australian New Zealand Clinical Trials Registry: ACTRN12621000124831 and ACTRN12619001477112.</p>","PeriodicalId":16382,"journal":{"name":"Journal of Medical Radiation Sciences","volume":" ","pages":""},"PeriodicalIF":2.1000,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13563419/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Medical Radiation Sciences","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1002/jmrs.70117","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction: We report a pooled analysis of two multicentre intra-patient randomised controlled trials (RCTs) comparing the silicone-based dressings Mepitel Film and StrataXRT for the prevention of acute radiation dermatitis (ARD) in postmastectomy radiotherapy (RT).
Methods: Each irradiated chest wall was divided into medial and lateral halves, randomised to one dressing each. The primary endpoint was the incidence of grade 2 or 3 ARD. Secondary endpoints included grade 3 ARD, moist desquamation, time to moist desquamation, Radiation-Induced Skin Reaction Assessment Scale (RISRAS) scores, adverse events, and treatment preferences. Discordant-pair methods, conditional logistic regression, paired comparisons of area under the curve (AUC), and longitudinal fixed-effects regression were used.
Results: A total of 120 patients (median age, 60 years; interquartile range, 51-69) were included (Australia, n = 40; New Zealand, n = 80); 64.2% received moderately hypofractionated or ultrahypofractionated RT. Among 38 discordant pairs, grade 2 or 3 ARD occurred only on the StrataXRT side in 30 patients and only on the Mepitel Film side in eight patients (odds ratio 3.75, 95% CI 1.72-8.18; p = 0.001). Grade 3 ARD and moist desquamation did not differ significantly. HCP-assessed RISRAS AUCs for erythema (p < 0.001) and moist desquamation (p = 0.034) were significantly lower with Mepitel Film, consistent with the longitudinal analyses. Patient-reported RISRAS AUCs did not differ between treatments. Treatment preferences were broadly balanced.
Conclusions: Mepitel Film reduced the incidence of grade 2 or 3 ARD and cumulative HCP-assessed erythema and moist desquamation burden compared with StrataXRT, while patient-reported symptom burden was similar. Selection of a prophylactic dressing for postmastectomy RT should consider patient preference, cost, ease of application, skin sensitivity, and available resources.
Trial registration: Australian New Zealand Clinical Trials Registry: ACTRN12621000124831 and ACTRN12619001477112.
期刊介绍：
Journal of Medical Radiation Sciences (JMRS) is an international and multidisciplinary peer-reviewed journal that accepts manuscripts related to medical imaging / diagnostic radiography, radiation therapy, nuclear medicine, medical ultrasound / sonography, and the complementary disciplines of medical physics, radiology, radiation oncology, nursing, psychology and sociology. Manuscripts may take the form of: original articles, review articles, commentary articles, technical evaluations, case series and case studies. JMRS promotes excellence in international medical radiation science by the publication of contemporary and advanced research that encourages the adoption of the best clinical, scientific and educational practices in international communities. JMRS is the official professional journal of the Australian Society of Medical Imaging and Radiation Therapy (ASMIRT) and the New Zealand Institute of Medical Radiation Technology (NZIMRT).
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
