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

Last updated: April 28, 2025
Sponsor: Nantes University Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Acne

Rash

Scalp Disorders

Treatment

5% benzoyl peroxide

Clinical Study ID

NCT04028401
RC19_0042
  • Ages > 18
  • Male

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male patients, Adult patients,

  • Patient without a history of surgical intervention on the operated shoulder,

  • Patient managed for glenohumeral, partial (cup or anatomical hemi- arthroplasty) ortotal (anatomical or inverted) glenohumeral arthroplasty placement for primaryosteoarthritis, or secondary to necrosis, massive rotator cuff tear or old fracture.

  • Patients affiliated to a social security system

  • Patients who have given their informed and written consent

Exclusion

Exclusion Criteria:

  • Patient with arthroplasty for resumption of previous shoulder surgery or failure ofarthroplasty

  • Patient with arthroplasty for acute trauma

  • Patient on immunosuppressantsimmunosuppressive drugs

  • Patient with inflammatory rheumatism

  • Patient with progressive cancer pathology

  • Allergies or intolerances concerning the modalities of selected skin preparations (Povidone Iodine, hypersensitivity to benzoyl peroxide)

  • Dermatological pathologies in the area to be treated

  • Acne treatment in the area to be treated within four weeks before inclusion

  • Patient without possible help from a third party for the application of Cutacnyl® 5%in the intervention group if necessary

  • Major under guardianship

  • Patient under the protection of justice

  • Patient not covered by social security

Study Design

Total Participants: 110
Treatment Group(s): 1
Primary Treatment: 5% benzoyl peroxide
Phase: 3
Study Start date:
June 19, 2020
Estimated Completion Date:
June 30, 2029

Connect with a study center

  • CHU d'Angers

    Angers, 49933
    France

    Active - Recruiting

  • CHU de Brest

    Brest, 29609
    France

    Active - Recruiting

  • CHU de Limoges

    Limoges, 87000
    France

    Active - Recruiting

  • CHU de Nantes

    Nantes, 44093
    France

    Active - Recruiting

  • Clinique Saint Michel Sainte Anne

    Quimper, 29000
    France

    Site Not Available

  • CHU de Rennes

    Rennes, 35000
    France

    Active - Recruiting

  • Clinique Alliance

    Saint-Cyr-sur-Loire, 37540
    France

    Site Not Available

  • Institut Locomoteur de l'Ouest

    Saint-Grégoire, 35760
    France

    Site Not Available

  • Santé Atlantique

    Saint-Herblain, 44819
    France

    Site Not Available

  • CHU de Toulouse

    Toulouse,
    France

    Site Not Available

  • CHU de Tours

    Tours, 37170
    France

    Active - Recruiting

  • CHBA

    Vannes,
    France

    Site Not Available

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