Clinical Trial: A Prospective Randomized Comparative Study of Preoperative Skin Preparation and Antiseptic Agents in Arthroscopic Shoulder Surgery (Japan)

Tokyo, Jan. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060219) titled 'A Prospective Randomized Comparative Study of Preoperative Skin Preparation and Antiseptic Agents in Arthroscopic Shoulder Surgery' on Jan. 1.

Study Type: Interventional

Study Design: Basic Design - Factorial Randomization - Randomized Blinding - Single blind -investigator(s) and assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Funabashi Orthopaedic Hospital

Condition: Condition - rotator cuff tear and recurrent shoudler dislocation Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to prospectively compare the preventive effects of benzoyl peroxide and hydrogen peroxide used as preoperative skin preparation against Cutibacterium acnes in patients undergoing arthroscopic shoulder surgery. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Standard preoperative skin disinfection using an alcohol-based chlorhexidine solution performed immediately before surgery. Interventions/Control_2 - Benzoyl peroxide is applied to the surgical site once daily on the day before surgery, followed by standard preoperative skin disinfection using an alcohol-based chlorhexidine solution on the day of surgery.

Eligibility: Age-lower limit - 12 years-old = Gender - Male and Female Key inclusion criteria - 1. Patients scheduled to undergo arthroscopic shoulder surgery for rotator cuff tear or recurrent shoulder dislocation at our institution 2. Patients who received an explanation of the study and provided written informed consent Key exclusion criteria - 1. Patients with a known allergy or hypersensitivity to benzoyl peroxide or hydrogen peroxide 2. Patients with active skin disorders at the surgical site 3. Patients judged to have markedly poor compliance with preoperative skin preparation using benzoyl peroxide Target Size - 200

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 10 Month 23 Day Date of IRB - 2025 Year 10 Month 23 Day Anticipated trial start date - 2026 Year 01 Month 01 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068876

Disclaimer: Curated by HT Syndication.