General Skin and Nasal Decolonization With Octenisan® Set Be-fore and After Elective Orthopedic Surgery in Selected Patients at Elevated Risk for Revision Surgery and Surgical Site Infections

Prov. Wissenschaftsantrag 980

The general decolonization of the human body surface by industrial antiseptic agents, before elective surgery is recommended by the World Health Organization (WHO). A specific randomized-controlled trial specifically among high-risk adult orthopedic patients for infection has not been performed. In this single-center, prospective, randomized, and controlled superiority trial, which is planned over a period of two years, we target on an orthopedic patient population with an elevated risk for revision surgery and surgical site infections

2023-02-27

2025-01-31

2025-04-30

Recruiting

Early phase I

1000

Inclusion Criteria: * Age ≥ 18 years * Patients with an age ≥ 80 years (as considered particularly at risk for SSI) * Elective orthopedic surgery at the Balgrist * Chronic immune-suppression (diabetes mellitus, active cancer, cirrhosis CHILD C, renal dialysis, untreated HIV disease, medicamentous immune-suppression equivalent to prednisone ≥ 10 mg/day) * Elective surgery in ischemic skin (e.g. major amputations) * Elective surgery on non-diabetic and non-infected ulcerated skin * Tumor (oncologic) orthopedic surgery * ASA-Scores 3-4 points Exclusion Criteria: * Elective revision orthopedic surgery due to orthopedic infection within the last 12 months in the same area of surgery * Emergency surgery (defined as planned surgery within the next 48 hours) * Surgery on infected skin; or surgery under antibiotic treatment for any reason * "Diabetic foot surgery" (distinct clinical entity; defined as below the ankle) * Body mass index ≥ 35 kg/m2 (anticipated difficulty of effective decolonization) * Pregnancy (formality reasons) * Intolerance or allergy to octenidin and/or ingredients in the Octenisan® set * Use of any other topical antiseptic agents other than Octenisan® set (except for the duration of one day) * Patient unable to understand; or under legal guardian for medical decisions * Anticipated clinical follow-up of less than 6 weeks after surgery. * ASA-Scores 1-2, and ASA-Score 5 (high risk of postoperative complications) * Known skin colonization with antibiotic-multiresistant Gram-negative organisms defined by infection control protocols of Switzerland1

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-Center, Unblinded, Superiority, Randomized-Controlled Trial (Randomization 1:1)', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1000, 'type': 'ESTIMATED'}}

2023-08-15