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.