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NCT05701475
Cutibacterium Acnes: Triple Prevention in Shoulder Operations
Conditions: Post-Operative Wound Infection, Surgical Site Infection
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 156
Sponsor: Clinique Générale dAnnecy
Location: France
Summary
Patients planned for shoulder surgery will be identified and contacted for participation.
After informed consent is provided, patients will be randomised into one of three groups: pre-operative cutaneous disinfection with iodine (control group), pre-operative cutaneous and subcutaneous disinfection with iodine (double prevention), and pre-operative cutaneous and subcutaneous disinfection with iodine combined with a skin preparation protocol with benzoyl peroxide gel in the days prior to surgery (triple prevention).
Bacterial cultures will be collected during surgery of the surgical field and tissue layers.
Culture positivity for Cutibacterium Acnes will be compared between the groups as a primary outcome.
Eligibility Criteria
Inclusion Criteria:Patients with an indication for all types of surgery at the shoulder joint, acromioclavicular joint, or clavicle, including arthroscopic and open surgery.Exclusion Criteria:Previous shoulder surgery, history of shoulder infection, antibiotic treatment in the last 6 weeks, allergy or hypersensitivity to one of the disinfecting agents, and patients with laboratory values consistent with a current infection (C-reactive protein, erythrocyte sedimentation rate, leukocyte count).
Source: ClinicalTrials.gov (NCT05701475). StuddyBuddy aggregates publicly available trial information.