General Decolonization With Octenisan® Set Before Elective Orthopedic Surgery

• Status: Not yet recruiting
• Trial end date: 2025-04-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Balgrist University Hospital
• Collaborator: Industry (Schülke & Mayr AG, Switzerland and Germany)

Criteria

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