ArticleBMJ open2026
Clinical efficacy of Mepilex Lite dressings combined with indomethacin suppositories in the treatment of acute radiation dermatitis caused by rectal cancer radiotherapy: a study protocol for a randomised controlled trial.
Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06837831 (Clinical Efficacy of Mepilex Lite Dressings Combined With Indomethacin Suppositories in the Treatment of Acute Radiation Dermatitis Caused by Rectal Cancer Radiotherapy), which is not on this map. Not yet cited in PubMed.
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Clinical Efficacy of Mepilex Lite Dressings Combined With Indomethacin Suppositories in the Treatment of Acute Radiation Dermatitis Caused by Rectal Cancer Radiotherapy: a Randomized Controlled Trial
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5 authors.
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Abstract
introductionAcute radiation dermatitis is a common adverse reaction in radiotherapy, especially in patients with rectal cancer undergoing radiotherapy. At present, acute radiation dermatitis of the perianal skin has received widespread attention; however, acute radiation skin injury of the anal canal skin has not received sufficient attention. These patients mainly complain of anal pain, which seriously affects their quality of life. Mepilex Lite dressings have been recommended for the treatment of acute radiation dermatitis and have a definite effect. However, there is limited research on the use of this dressing for the treatment of acute radiation-induced dermatitis of the anal canal skin and its clinical efficacy and safety in this context need further verification. METHODS AND ANALYSIS: This study is an assessor-blinded randomised controlled trial designed to evaluate the efficacy and safety of Mepilex Lite dressings combined with indomethacin suppositories for the treatment of acute radiation dermatitis of the anal canal skin. A total of 274 eligible patients from the tumour radiotherapy ward of the First Affiliated Hospital of Shandong First Medical University will be randomly assigned to either the experiment or control group (1:1). The control group will be given 30 mg of indomethacin suppositories for rectal administration, and the experiment group will be given Mepilex Lite dressings in addition to the measures taken by the control group. The 5 cm × 5 cm dressing will be inserted into the anal canal for 3 cm through the anus and exposed for 2 cm. The main outcome indicator is the treatment efficiency of the acute radiation dermatitis of the anal canal skin on the 14th day after the intervention. The secondary outcome indicator is the treatment efficiency of the acute radiation dermatitis of the anal canal skin on the seventh and 21st days after the intervention. Concurrently, the Numeric Rating Scale, Hospital Anxiety and Depression Scale, Pittsburgh Sleep Quality Index and Skin Disease Patient Quality of Life Scale-16 will be used to assess patient pain, depression and anxiety, sleep quality and quality of life, respectively. A table questionnaire survey will be conducted at baseline and on 7, 14 and 21 days after intervention. ETHICS AND DISSEMINATION: The research protocol has obtained ethical approval from the Ethics Committee of the First Affiliated Hospital of Shandong First Medical University (approval number: YXLL-KY-2024 (162)). The results will be published in peer-reviewed journals and abstracts will be submitted to domestic and international conferences to disseminate our research findings. TRIAL REGISTRATION NUMBER: NCT06837831.
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