Tokyo, Aug. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062679) titled 'PD Infection Prevention MA-T Study' on Aug. 25.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Kurume University

Condition: Condition - Patients undergoing peritoneal dialysis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to prospectively evaluate the efficacy, safety, and feasibility of exit-site care using the investigational product MA-T for the prevention of peritoneal dialysis-related infections in patients undergoing peritoneal dialysis. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - In the new exit-site care group, the conventional disinfectant will be replaced with the investigational product MA-T. Peritoneal dialysis catheter exit-site care will be performed once daily for 12 months. After cleansing and drying the exit site, MA-T will be applied to the exit site with three sprays (3-5 mL), followed by gauze coverage without waiting for drying. In addition, hand disinfection using MA-T will be performed after handwashing immediately before peritoneal dialysis treatment, and three sprays (0.5-1 mL) of the oral MA-T formulation will be applied to the oral cavity after routine oral care. These interventions will be continued for 12 months. Interventions/Control_2 - Conventional peritoneal dialysis catheter exit-site care routinely performed at Kurume University Hospital will be continued. Other peritoneal dialysis treatment and usual clinical care will be provided as usual. The observation period is 12 months.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients who are continuing peritoneal dialysis treatment at Kurume University Hospital and are between 90 days and 2 years after initiation of peritoneal dialysis. Patients who are in a clinically stable condition. Patients who have had no peritoneal dialysis-related infection for at least 90 days. Patients who have received sufficient information about the study and provided written informed consent to participate. Patients who are considered able to continue the scheduled exit-site care and exit-site assessments during the study period. Key exclusion criteria - Patients with active exit-site infection at the time of enrollment. Patients with active tunnel infection at the time of enrollment. Patients undergoing treatment for peritoneal dialysis-related peritonitis at the time of enrollment. Patients who are unable to undergo the specified exit-site care because of skin lesions or other conditions at the exit site. Patients considered at risk of developing allergic reactions or skin disorders associated with the use of MA-T. Patients considered unsuitable for participation in the study by the principal investigator or other investigators. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 27 Day Anticipated trial start date - 2026 Year 11 Month 01 Day Last follow-up date - 2029 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071763

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