RecruitingPhase 3NCT04028401

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

Enrollment

110 participants

Start Date

Jun 19, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at the best way to prepare the skin before shoulder replacement surgery to reduce the risk of infection from a common bacteria called Cutibacterium acnes. This bacteria lives naturally on the skin, especially around the shoulder, and can sometimes contaminate the surgical site during joint replacement procedures. Researchers are comparing different skin preparation methods to find out which approach most effectively reduces bacterial contamination. Only male patients scheduled for shoulder replacement surgery are included, as men tend to have higher levels of this particular bacteria on their skin. You may be eligible if: - You are a male patient aged 18 or older - You have no history of prior surgery on the affected shoulder - You are scheduled for glenohumeral shoulder arthroplasty (partial or total) for osteoarthritis, avascular necrosis, massive rotator cuff tear, or old fracture - You are affiliated with a social security system and have given written consent You may NOT be eligible if: - You are having revision surgery or surgery for acute trauma - You are taking immunosuppressive drugs or have inflammatory rheumatism - You have progressive cancer - You have allergies to the skin preparation products used (Povidone Iodine, benzoyl peroxide) - You have a skin condition or active acne treatment in the shoulder area Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG5% 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

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NCT04028401