General Decolonization With Octenisan® Set Before Elective Orthopedic Surgery (BALGDEC)
Elective Surgery, High Risk, Prevention of Surgical Site Infections
About this trial
This is an interventional prevention trial for Elective Surgery focused on measuring Body and nasal decolonization, Adult orthopedic surgery, Prevention of Surgical Site Infections, Randomized-controlled trial
Eligibility 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
Sites / Locations
- Balgrist University Hospital
- Balgrist University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Decolonization
Non-Decolonization
This study will be performed with an existing "set" manufactured by Schülke & Mayr GmbH. The distribution of octenisan® wash lotion and octenisan® nasal gel in the form of a set (octenisan® set) largely streamlines and facilitates the application and compliance. The duration of pre-surgical decolonization is planned to be five days. However, when this pre-surgical time period is too short, the decolonization may also start at least 3 days before surgery and be contin-ued up to 2 days post-surgery. During the post-surgery application, the patient will be washed with water and Octenisan® set by their treating nurses. The patient will also return the empty/used set and answer to a short questionnaire during their hospital stay. The study team will recuperate the questionnaire during hospitalization.
No Decolonization preoperatively