Elective Surgery Clinical Trial
— BALGDECOfficial title:
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
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
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | April 30, 2025 |
Est. primary completion date | January 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Balgrist University Hospital | Zürich | Zurich |
Switzerland | Balgrist University Hospital | Zürich |
Lead Sponsor | Collaborator |
---|---|
Balgrist University Hospital | Industry (Schülke & Mayr AG, Switzerland and Germany) |
Switzerland,
Dancer SJ, Christison F, Eslami A, Gregori A, Miller R, Perisamy K, Robertson C, Graves N. Is it worth screening elective orthopaedic patients for carriage of Staphylococcus aureus? A part-retrospective case-control study in a Scottish hospital. BMJ Open. — View Citation
Prentice HA, Chan PH, Champsi JH, Clutter DS, Maletis GB, Mohan V, Namba RS, Reddy NC, Hinman AD, Fang AS, Yian E, Navarro RA, Norheim EP, Paxton EW. Temporal Trends in Deep Surgical Site Infections After Six Orthopaedic Procedures Over a 12-year Period W — View Citation
Rohrer F, Notzli H, Risch L, Bodmer T, Cottagnoud P, Hermann T, Limacher A, Fankhauser N, Wagner K, Brugger J. Does Preoperative Decolonization Reduce Surgical Site Infections in Elective Orthopaedic Surgery? A Prospective Randomized Controlled Trial. Cli — View Citation
Tsang STJ, McHugh MP, Guerendiain D, Gwynne P, Boyd J, Laurenson IF, Templeton KE, Lewis S, Simpson AHRW, Walsh TS. Evaluation of Staphylococcus aureus eradication therapy in orthopaedic surgery. J Med Microbiol. 2018 Jun;67(6):893-901. doi: 10.1099/jmm.0 — View Citation
Uckay I, Hoffmeyer P, Lew D, Pittet D. Prevention of surgical site infections in orthopaedic surgery and bone trauma: state-of-the-art update. J Hosp Infect. 2013 May;84(1):5-12. doi: 10.1016/j.jhin.2012.12.014. Epub 2013 Feb 14. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Remission (and inversely surgical site infection) | Remission is defined as the absence of clinical, anamnestic, radiologic or laboratory signs of infection. | At 6 weeks after elective orthopedic surgery; or at 1 year for surgeries with orthopedic implants | |
Primary | Wound problems after elective surgery | Wound problems (dehiscence, seroma, hematoma, necrosis) occurring after surgery | Until week 6 after surgery | |
Secondary | Unplanned revision surgery for non-infection problems in same time period | Any revision in the operating theatre due to non-infectious pathologies | At 6 weeks after elective orthopedic surgery; or at 1 year for surgeries with orthopedic implants | |
Secondary | Adverse events | All adverse events during the decolonization and hospitalization periods | At 6 weeks after elective orthopedic surgery; or at 1 year for surgeries with orthopedic implants | |
Secondary | Subjective opinion and information on the decolonization | Questionnaire with 5 questions only for patients being decolonized | A day within one week after surgery (during the hospitalization) |
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