Preventing infections in shoulder surgery using different disinfection methods
Triple Prevention Against Cutibacterium Acnes Using Benzoyl Peroxide Preparation in Addition to Pre-operative Cutaneous and Subcutaneous Iodine in Shoulder Surgery; a Single-blinded, Randomized, Controlled Trial.
This study is testing three different ways to clean the skin before shoulder surgery to see which method best prevents infections in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinique Générale dAnnecy Academic / other |
| Locations | 1 site (Annecy) |
| Trial ID | NCT05701475 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of three different disinfection protocols to prevent post-operative infections in patients undergoing shoulder surgery. Participants will be randomly assigned to one of three groups: a control group receiving only cutaneous iodine, a double prevention group receiving both cutaneous and subcutaneous iodine, and a triple prevention group using benzoyl peroxide in addition to the iodine treatments. Bacterial cultures will be collected during surgery to assess the presence of Cutibacterium Acnes, with the goal of determining which method is most effective in reducing infection rates. The study will include a total of 156 patients, with equal representation from both arthroscopic and open surgical procedures.
Who should consider this trial
Good fit: Ideal candidates are individuals scheduled for shoulder surgery who meet the inclusion criteria.
Not a fit: Patients with a history of shoulder surgery or current infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of post-operative infections in shoulder surgeries.
How similar studies have performed: While similar approaches have been explored, this specific combination of disinfection methods has not been extensively tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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; * Patients with laboratory values consistent with a current infection (C-reactive protein, erythrocyte sedimentation rate, leukocyte count).
Where this trial is running
Annecy
- Clinique Générale d'Annecy — Annecy, France (Recruiting)
Study contacts
- Principal investigator: Geert A Buijze, MD, PhD — Clinique Générale d'Annecy
- Study coordinator: Geert A Buijze, MD, PhD
- Email: gabuijze@hotmail.com
- Phone: +33450330950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.