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

Primary Purpose

Cutibacterium Acnes Infection

Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
5% benzoyl peroxide
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cutibacterium Acnes Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHU d'AngersRecruiting
  • CHU de BrestRecruiting
  • CHU de NantesRecruiting
  • Clinique Saint Michel Sainte AnneRecruiting
  • CHU de RennesRecruiting
  • Institut Locomoteur de l'OuestRecruiting
  • Santé AtlantiqueRecruiting
  • CHU de Toulouse
  • CHU de ToursRecruiting
  • CHBARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

5 % benzoyl peroxide topical treatment

No topical treatment

Arm Description

Application of 5% benzoyl peroxide

No intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Average number of positive intraoperative Cutibacterium acnes samples
samples taken at he cutaneous level before and after cutaneous antisepsis of the operating area before incision, fat and capsular.
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
Incidence of Cutibacterium acnes shoulder prosthesis infections up to 2 years after shoulder prosthesis implantation in both study groups
Phylotype
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
Cutibacterium acnes strains
Comparison of Cutibacterium acnes strains by molecular biology
Antibiotic resistance
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
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)

Full Information

First Posted
July 17, 2019
Last Updated
January 9, 2023
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04028401
Brief Title
Optimization of Skin Preparation to Reduce Cutibacterium Acnes Colonization in Superficial and Deep Samples During Prosthetic Shoulder Surgery in Male Patients
Acronym
OPRICA
Official Title
Optimization of Skin Preparation to Reduce Cutibacterium Acnes Colonization in Superficial and Deep Samples During Prosthetic Shoulder Surgery in Male Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2020 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutibacterium Acnes Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
5 % benzoyl peroxide topical treatment
Arm Type
Experimental
Arm Description
Application of 5% benzoyl peroxide
Arm Title
No topical treatment
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
5% benzoyl peroxide
Intervention Description
Application of 5% benzoyl peroxide during 5 days before the procedure
Primary Outcome Measure Information:
Title
Number of patients in each group with a positive Cutibacterium acnes sample at the dermis.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Average number of positive intraoperative Cutibacterium acnes samples
Description
samples taken at he cutaneous level before and after cutaneous antisepsis of the operating area before incision, fat and capsular.
Time Frame
Day 0
Title
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
Title
Incidence of Cutibacterium acnes shoulder prosthesis infections up to 2 years after shoulder prosthesis implantation in both study groups
Time Frame
2 years
Title
Phylotype
Description
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
Title
Cutibacterium acnes strains
Description
Comparison of Cutibacterium acnes strains by molecular biology
Time Frame
Day 0
Title
Antibiotic resistance
Time Frame
Day 0
Title
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
Description
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)
Time Frame
Day 0

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphane CORVEC
Phone
0240083955
Ext
+33
Email
stephane.corvec@chu-nantes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane CORVEC
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU d'Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent HUBERT
Email
LaHubert@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Laurent HUBERT
Facility Name
CHU de Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hoel LETISSIER
Email
hoel.letissier@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
Hoel LETISSIER
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane CORVEC
First Name & Middle Initial & Last Name & Degree
Marc CAPELLI
Facility Name
Clinique Saint Michel Sainte Anne
City
Quimper
ZIP/Postal Code
29000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre SONNARD
Email
a.sonnard@orange.fr
First Name & Middle Initial & Last Name & Degree
Alexandre SONNARD
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hervé THOMAZEAU
Email
herve.thomazeau@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Hervé THOMAZEAU
Facility Name
Institut Locomoteur de l'Ouest
City
Saint-Grégoire
ZIP/Postal Code
35760
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent BAVEREL
Email
l.baverel@gmail.com
First Name & Middle Initial & Last Name & Degree
Laurent BAVEREL
Facility Name
Santé Atlantique
City
Saint-Herblain
ZIP/Postal Code
44819
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu BOISSARD
Email
drboissard@polyclinique-atlantique.fr
First Name & Middle Initial & Last Name & Degree
Mathieu BOISSARD
First Name & Middle Initial & Last Name & Degree
Yves BOUJU
Facility Name
CHU de Toulouse
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre MANSAT, Pr
Email
mansat.p@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Pierre MANSAT, Pr
Facility Name
CHU de Tours
City
Tours
ZIP/Postal Code
37170
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc FAVARD
Email
luc.favard@univ-tours.fr
First Name & Middle Initial & Last Name & Degree
Luc FAVARD
Facility Name
CHBA
City
Vannes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David TOURAINE, Dr
Phone
02.97.01.42.56
Email
david.touraine@ch-bretagne-atlantique.fr
First Name & Middle Initial & Last Name & Degree
David TOURAINE, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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