NCT04028401

Optimization of Skin Preparation to Reduce Cutibacterium Acnes Colonization in Superficial and Deep Samples During Prosthetic Shoulder Surgery in Male Patients

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Infections on joint replacements remain one of the most serious complications of orthopaedic surgery. Despite improvements in skin preparation and antibiotic prophylaxis procedures, the risk of infection of joint prosthesis is still high, particularly for shoulder prostheses, especially in men. One of the bacteria most often involved in post-operative infections for shoulder prosthesis is Cutibacterium acnes (CA). This bacterium is one of the predominant bacteria in pilosebaceous units. Eradication of this micro-organism remains difficult despite the techniques used in the preoperative phase. The objective of this protocol is to evaluate the efficacy of applying a 5% benzoyl peroxide topical during the 5 days preceding the procedure in the surgical skin incision area, which is based on local acne treatment, on the reduction of the CA bacterial load in the dermis of the approach to shoulder arthroplasty in men.

Conditions

• Cutibacterium Acnes Infection

Interventions

Type	Name	Description
DRUG	5% benzoyl peroxide	Application of 5% benzoyl peroxide during 5 days before the procedure

Timeline

• Start date: 2020-06-19
• Primary completion: 2029-06-01
• Completion: 2029-06-01
• First posted: 2019-07-22
• Last updated: 2025-05-01

Locations

6 sites across 1 country: France