CSMed^® wound dressing for prophylaxis and management of radiation dermatitis in breast and head-neck cancer patients: a single hospital prospective clinical trial.

"Declarations Conflict of interestThe authors declare that they have no competing interests. Ethics approval and consent to participateThis trial was designed and conducted in accordance with the principles outlined in the Declaration of Helsinki and within the guidelines of Good Clinical Practices (trial registration numbers: NCT06001463, August 23, 2023). This trial was approved by the Institutional Review Board of the Chung Shan Medical University Hospital (212250-017-F-001). A written informed consent with respect to the use of topical agents and clinical data management for research purposes was obtained from all participants. Conflict of interest The authors declare that they have no competing interests."

"Funding None."

"Patients arranged to receive radiation therapy between August 2020 and December 2020 were recruited for this study. The inclusion criteria were (1) patient were diagnosed with breast cancer or head-and-neck cancer; (2) patients aged between 20 and 70; and (3) patients underwent radiation therapy. The exclusion criteria were (1) patients had dermatitis or burns which is not induced by radiation therapy; (2) patients whom did not apply CSMed® dressing for 2 consecutive days, necessary to ensure consistent treatment efficacy; (3) patients whom cannot complete the whole treatment and follow-up procedures; and (4) patient who are allergic to the ingratiation of the CSMed® dressing. A written informed consent with respect to the use of topical agents and clinical data management for research purposes was obtained from all participants. This trial was designed and conducted in accordance with the principles outlined in the Declaration of Helsinki and within the guidelines of Good Clinical Practices (trial registration numbers: NCT06001463, August 23, 2023). This trial was approved by the Institutional Review Board of the Chung Shan Medical University Hospital (212250-017-F-001). Declarations: Conflict of interestThe authors declare that they have no competing interests.: Ethics approval and consent to participateThis trial was designed and conducted in accordance with the principles outlined in the Declaration of Helsinki and within the guidelines of Good Clinical Practices (trial registration numbers: NCT06001463, August 23, 2023). This trial was approved by the Institutional Review Board of the Chung Shan Medical University Hospital (212250-017-F-001). A written informed consent with respect to the use of topical agents and clinical data management for research purposes was obtained from all participants. Ethics approval and consent to participate: This trial was designed and conducted in accordance with the principles outlined in the Declaration of Helsinki and within the guidelines of Good Clinical Practices (trial registration numbers: NCT06001463, August 23, 2023). This trial was approved by the Institutional Review Board of the Chung Shan Medical University Hospital (212250-017-F-001). A written informed consent with respect to the use of topical agents and clinical data management for research purposes was obtained from all participants."