Optimization of skin preparation to reduce Cutibacterium acnes colonization in superficial and deep samples during prosthetic shoulder surgery in male patients

Phase 1

• Conditions: Cutibacterium acnes infection in shoulder arthroplasty with males; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-001419-21-FR
• Lead Sponsor: CHU de Nantes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-01
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

? Patient with arthroplasty for resumption of previous shoulder surgery or failure of arthroplasty
? Patient with arthroplasty for acute trauma
? Patient on immunosuppressive drugs
? Patient with inflammatory rheumatism
? Patient with progressive cancer pathology
? Allergies or intolerances concerning the modalities of selected skin preparations (Povidone Iodine, cefazolin, 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 clinical trial of medicinal product
• Study Design: Not specified