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

January 9, 2023 updated by: Nantes University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France, 49933
        • Recruiting
        • CHU d'Angers
        • Principal Investigator:
          • Laurent HUBERT
        • Contact:
      • Brest, France, 29609
      • Nantes, France, 44093
        • Recruiting
        • CHU de Nantes
        • Contact:
          • Stéphane CORVEC
        • Principal Investigator:
          • Marc CAPELLI
      • Quimper, France, 29000
        • Recruiting
        • Clinique Saint Michel Sainte Anne
        • Contact:
        • Principal Investigator:
          • Alexandre SONNARD
      • Rennes, France, 35000
      • Saint-Grégoire, France, 35760
        • Recruiting
        • Institut Locomoteur de l'Ouest
        • Contact:
        • Principal Investigator:
          • Laurent BAVEREL
      • Saint-Herblain, France, 44819
      • Toulouse, France
        • Not yet recruiting
        • CHU de Toulouse
        • Contact:
        • Principal Investigator:
          • Pierre MANSAT, Pr
      • Tours, France, 37170
      • Vannes, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5 % benzoyl peroxide topical treatment
Application of 5% benzoyl peroxide
Drug: 5% benzoyl peroxide
Application of 5% benzoyl peroxide during 5 days before the procedure
No Intervention: No topical treatment
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients in each group with a positive Cutibacterium acnes sample at the dermis.
Time Frame: Day 0
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: Day 0
Day 0
Incidence of Cutibacterium acnes shoulder prosthesis infections up to 2 years after shoulder prosthesis implantation in both study groups
Time Frame: 2 years
2 years
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
Day 0
Cutibacterium acnes strains
Time Frame: Day 0
Comparison of Cutibacterium acnes strains by molecular biology
Day 0
Antibiotic resistance
Time Frame: Day 0
Day 0
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)
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Stéphane CORVEC, CHU de Nantes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2020

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

July 17, 2019

First Submitted That Met QC Criteria

July 18, 2019

First Posted (Actual)

July 22, 2019

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC19_0042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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