NCT04028401|RecruitingPhase 3
Optimization of Skin Preparation to Reduce Cutibacterium Acnes Colonization in Superficial and Deep Samples During Prosthetic Shoulder Surgery in Male Patients
OPRICA
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Sponsor study identifier
interventional
110
1 country
6
Study Start
June 19, 2020
Actual (reported)Primary Completion
June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 17, 2019
Actual (reported)July 22, 2019
Actual (reported)June 19, 2020
Actual (reported)June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Number of patients in each group with a positive Cutibacterium acnes sample at the dermis.
Day 0
Average number of positive intraoperative Cutibacterium acnes samples
Day 0
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
Cutibacterium acnes strains
Day 0
Application of 5% benzoyl peroxide
No intervention
Application of 5% benzoyl peroxide during 5 days before the procedure
CHU d'Angers
Angers, 49933, France
CHU de Brest
Brest, 29609, France
Stéphane CORVEC
Nantes University Hospital
First Submitted
July 17, 2019
First Posted
July 22, 2019
Study Start
June 19, 2020
Actual (reported)Primary Completion
June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
A Study of Efficacy of Benzoyl Peroxide Regimens in Treatment of Unpleasant Foot Odor
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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CHU de Limoges
Limoges, 87000, France
CHU de Nantes
Nantes, 44093, France
CHU de Rennes
Rennes, 35000, France
CHU de Tours
Tours, 37170, France
Study Completion
June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 1, 2025
Record last verified: 2025-04
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