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RECRUITING
NCT04028401
PHASE3

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

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2020-06-19

Completion Date

2029-06

Last Updated

2025-05-01

Healthy Volunteers

No

Interventions

DRUG

5% benzoyl peroxide

Application of 5% benzoyl peroxide during 5 days before the procedure

Locations (6)

CHU d'Angers

Angers, France

CHU de Brest

Brest, France

CHU de Limoges

Limoges, France

CHU de Nantes

Nantes, France

CHU de Rennes

Rennes, France

CHU de Tours

Tours, France