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NCT Number: NCT04028401

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

CHU d'Angers, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5% benzoyl peroxide

Drug

Application of 5% benzoyl peroxide during 5 days before the procedure

Primary outcomes

  1. Number of patients in each group with a positive Cutibacterium acnes sample at the dermis.

    Time frame: Day 0

Secondary outcomes

  1. Average number of positive intraoperative Cutibacterium acnes samples

    Time frame: Day 0

    samples taken at he cutaneous level before and after cutaneous antisepsis of the operating area before incision, fat and capsular.

  2. 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

    Time frame: Day 0

  3. Incidence of Cutibacterium acnes shoulder prosthesis infections up to 2 years after shoulder prosthesis implantation in both study groups

    Time frame: 2 years

  4. Phylotype

    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

  5. Cutibacterium acnes strains

    Time frame: Day 0

    Comparison of Cutibacterium acnes strains by molecular biology

  6. Antibiotic resistance

    Time frame: Day 0

  7. Evaluation of the skin tolerance of the topical application from the skin tolerance scale (irritation, erythema and desquamation), at the time of inclusion and at D0

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Stéphane CORVEC

CONTACT

[email protected]

0240083955 ext. +33

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: OPRICA

Important dates

Study start
2020
Primary completion
2029
Study completion
2029
First posted
Jul 22, 2019
Registry last updated
May 1, 2025

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.