Optimization of Skin Preparation to Reduce Cutibacterium Acnes Colonization in Superficial and Deep Samples During Prosthetic Shoulder Surgery in Male Patients (OPRICA)

Study of a Skin Treatment to Lower Infection Risk in Male Shoulder Replacement Surgery

Primary Investigator
U

User 2

Primary Investigator

Recruiting
18 years or above
Male
Phase 3
110 participants needed
7 Locations

Brief description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cutibacterium Acnes Infection
  • Age: 18 years or above
  • Gender: Male

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

Exclusion Criteria:

  • Patient with arthroplasty for resumption of previous shoulder surgery or failure of arthroplasty
  • Patient with arthroplasty for acute trauma
  • Patient on immunosuppressantsimmunosuppressive drugs
  • Patient with inflammatory rheumatism
  • Patient with progressive cancer pathology
  • Allergies or intolerances concerning the modalities of selected skin preparations (Povidone Iodine, 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

The purpose of this research study is to learn whether using a skin cream before shoulder replacement surgery can lower the amount of a bacteria called Cutibacterium acnes on and under the skin. This bacteria is a common cause of infection after shoulder joint replacement, especially in men. The study is for adult men who are having a shoulder joint replacement for certain shoulder problems.

Participants will use a 5% benzoyl peroxide skin treatment on the area where the surgeon will make the cut for surgery. It will be applied during the 5 days before the operation. The study team will compare how much Cutibacterium acnes is found in skin samples taken during the shoulder replacement surgery.

Who can participate:
Adult men may be able to participate if they:

  • Are scheduled for a partial or total shoulder joint replacement for primary osteoarthritis, or for osteoarthritis caused by necrosis, a massive rotator cuff tear, or an old fracture
  • Have not had surgery on the shoulder that will be operated on
  • Are covered by a social security system

Study timeline and visits:
Participants will apply the skin treatment for 5 days before their shoulder replacement surgery.

Updated on 28 Apr 2025. Study ID: RC19_0042

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