5% benzoyl peroxide
DrugApplication of 5% benzoyl peroxide during 5 days before the procedure
NCT Number: NCT04028401
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.
Interested in participating?
Request Info18 year and older
Male
Interventional
Phase 3
CHU d'Angers, Angers, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Application of 5% benzoyl peroxide during 5 days before the procedure
Time frame: Day 0
Time frame: Day 0
samples taken at he cutaneous level before and after cutaneous antisepsis of the operating area before incision, fat and capsular.
Time frame: Day 0
Time frame: 2 years
Time frame: 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
Time frame: Day 0
Comparison of Cutibacterium acnes strains by molecular biology
Time frame: Day 0
Time frame: 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)
Contact information is provided by the study sponsor or research team.
Nantes University Hospital
Other
Acronym: OPRICA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.