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

Phase 3

Recruiting

• Conditions: Cutibacterium Acnes Infection
• Interventions: Drug: 5% benzoyl peroxide

• Registration Number: NCT04028401
• Lead Sponsor: Nantes University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-18
• Study First Posted: 2019-07-22
• Study Start: 2020-06-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Primary Completion: 2029-06
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 110

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) or total (anatomical or inverted) glenohumeral arthroplasty placement for primary osteoarthritis, 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 Criteria

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5 % benzoyl peroxide topical treatment	5% benzoyl peroxide	Application of 5% benzoyl peroxide

Primary Outcome Measures

Name	Time	Method
Number of patients in each group with a positive Cutibacterium acnes sample at the dermis.	Day 0

Secondary Outcome Measures

Name	Time	Method
Cutibacterium acnes strains	Day 0	Comparison of Cutibacterium acnes strains by molecular biology
Average number of positive Cutibacterium acnes skin samples before and after alcoholic surgical site antisepsis (5% alcoholic iodine povidone) in each of the two study groups	Day 0
Incidence of Cutibacterium acnes shoulder prosthesis infections up to 2 years after shoulder prosthesis implantation in both study groups	2 years
Phylotype	Day 0	Determination of phylotype by molecular typing by Multi-Locus Sequence Typing and Single-Locus Sequence Typing techniques and comparison of Cutibacterium acnes strains by molecular biology and characterization of antibiotic resistance
Average number of positive intraoperative Cutibacterium acnes samples	Day 0	samples taken at he cutaneous level before and after cutaneous antisepsis of the operating area before incision, fat and capsular.
Antibiotic resistance	Day 0
Evaluation of the skin tolerance of the topical application from the skin tolerance scale (irritation, erythema and desquamation), at the time of inclusion and at D0	Day 0	skin tolerance scale evaluates local tolerance (absent: 0, light:1, moderate: 2 severe:3), erythema (absent:0, light:1, moderate:2, severe:3, very severe:4) and desquamation (absent: 0, light: 1, moderate: 2, severe: 3, very severe: 4)

Trial Locations

Locations (6)

CHU de Limoges; 🇫🇷 Limoges, France

CHU d'Angers; 🇫🇷 Angers, France

CHU de Brest; 🇫🇷 Brest, France

CHU de Nantes; 🇫🇷 Nantes, France

CHU de Rennes; 🇫🇷 Rennes, France

CHU de Tours; 🇫🇷 Tours, France