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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

Study acronym: OPRICA
StatusRecruiting
PhasePhase 3
Started2020-06-19
View on ClinicalTrials.gov ↗

Amendment history

2025-04-28
minor
Study Status, Contacts/Locations v9
Primary completion date2027-06→2029-06
Completion date2027-06→2029-06
Study sites10→6
2023-11-08
minor
Study Status v8
Primary completion date2025-06→2027-06
Completion date2025-06→2027-06
2023-01-09
minor
Study Status, Contacts/Locations v7
Study sitescontacts updated at 1 of 10 sites
2022-06-16
minor
Study Status, Eligibility, Contacts/Locations v6
Primary completion date2024-06→2025-06
Completion date2024-06→2025-06
Study sites9→10
Eligibility criteria-11 characters
[...] modalities of selected skin preparations (Povidone Iodine, cefazolin, hypersensitivity to benzoyl peroxide) Dermatological patholo [...]
2021-11-17
minor
Study Status, Contacts/Locations v5
Study sitesdetails revised at 1 of 9 sites
Show 4 earlier versions
2021-10-15
minor
Study Status v4
Re-verified, no change to tracked fields
2021-05-31
minor
Study Status, Contacts/Locations v3
Primary completion date2023-06→2024-06
Completion date2023-06→2024-06
Study sites9 entries, revised
Clinique AllianceCHBA
2020-07-15
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2022-11→2023-06
Completion date2022-11→2023-06
Start dateestimated 2019-11→confirmed 2020-06-19
Study sites10→9
2019-10-03
minor
Study Status v1
Primary completion date2022-09→2022-11
Completion date2022-09→2022-11
Start date2019-09→2019-11
2019-07-18
minor
Original filing
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.
Trial Details
NCT Number NCT04028401
Lead Sponsor Nantes University Hospital
Conditions Cutibacterium Acnes Infection
Enrollment 110 participants
Start Date 2020-06-19
Primary Completion 2029-06 (estimated)
Study Completion 2029-06 (estimated)
Updated on ClinicalTrials.gov 2025-05-01