General Skin and Nasal Decolonization with octenisan® Set before and after Elective Orthopedic Surgery in Selected Patients at Elevated Risk for Revision Surgery and Surgical Site Infections - A Single-Center, Unblinded, Superiority, Randomized-Controlled Trial (BALGDEC Trial)

Abstract

Background The preoperative body surface and nasal decolonization may reduce the risk of surgical site infections (SSI), but yields conflicting results in the current orthopedic literature. Methods We perform a single-center, randomized-controlled, superiority trial in favor of the preoperative decolonization using a commercial product (octenidin® set). We will randomize a total number of 1,000 adult elective orthopedic patients with a high risk for SSI and/or wound complications (age ≥ 80 years, chronic immune-suppression, American Society of Anesthesiologists’-Score 3–4 points) between a decolonization (octenisan® wash lotion 1 x per day and octenisan® md nasal gel 2–3 x per day; during five days) and no decolonization. Decolonized patients will additionally fill a questionnaire regarding the practical difficulties, the completeness, and the adverse events of decolonization. The primary outcomes are SSI and revision surgeries for postoperative wound problems until six weeks postoperatively (or 1 year for surgeries with implants or bone). Secondary outcomes are unplanned revision surgeries for non-infectious problems and all adverse events. With 95% event-free surgeries in the decolonization arm versus 90% in the control arm, we formally need 2 x 474 elective orthopedic surgeries included during two years. Discussion In selected adult orthopedic patients with a high risk for SSI, the presurgical decolonization may reduce postoperative wound problems, including SSI. Trial registration ClinicalTrial.gov NCT05647252. Registered on 9 December 2022. Protocol version 2 (5 December 2022)