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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 (OPRICA)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515584-56-00
Acronym
RC19_0042
Enrollment
110
Registered
2024-10-21
Start date
2020-06-19
Completion date
Unknown
Last updated
2025-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutibacterium acnes infection in shoulder arthroplasty with males

Brief summary

Number of patients in each group (interventional: benzoyl peroxide 5% for 5 days or control) with a positive Cutibacterium acnes sample at the dermis.

Detailed description

Average number of positive intraoperative Cutibacterium acnes samples taken at the cutaneous level before and after cutaneous antisepsis of the operating area before incision, fat and capsular. The skin sample at inclusion will allow the initial cutaneous Cutibacterium acnes bacterial load to be compared between both groups, 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, Incidence of Cutibacterium acnes shoulder prosthesis infections up to 2 years after shoulder prosthesis implantation in both study groups, Determination of phylotype, 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, Evaluation of the skin tolerance of the topical application from the local tolerance scale (irritation, erythema and desquamation), at the time of inclusion and at D0

Interventions

DRUGCUTACNYL 5 POUR CENT
DRUGgel pour application locale
DRUGBETADINE ALCOOLIQUE 5%
DRUGsolution pour application cutanée en récipient unidose

Sponsors

Centre Hospitalier Universitaire De Nantes
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Number of patients in each group (interventional: benzoyl peroxide 5% for 5 days or control) with a positive Cutibacterium acnes sample at the dermis.

Secondary

MeasureTime frame
Average number of positive intraoperative Cutibacterium acnes samples taken at the cutaneous level before and after cutaneous antisepsis of the operating area before incision, fat and capsular. The skin sample at inclusion will allow the initial cutaneous Cutibacterium acnes bacterial load to be compared between both groups, 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, Incidence of Cutibacterium acnes shoulder prosthesis infections up to 2 years after shoulder prosthesis implantation in both study groups, Determination of phylotype, 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, Evaluation of the skin tolerance of the topical application from the local tolerance scale (irritation, erythema and desquam

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026