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

NCT04028401 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-05-01

No results posted yet for this study

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

DRUG

5% benzoyl peroxide

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

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Stéphane CORVEC · Nantes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-19
Primary Completion
2029-06-30
Completion
2029-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04028401 on ClinicalTrials.gov