Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 29 of 134 for:    acne AND peroxide

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04028401
Recruitment Status : Not yet recruiting
First Posted : July 22, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.


Condition or disease Intervention/treatment Phase
Cutibacterium Acnes Infection Drug: 5% benzoyl peroxide Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Optimization of Skin Preparation to Reduce Cutibacterium Acnes Colonization in Superficial and Deep Samples During Prosthetic Shoulder Surgery in Male Patients
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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



Primary Outcome Measures :
  1. Number of patients in each group with a positive Cutibacterium acnes sample at the dermis. [ Time Frame: Day 0 ]

Secondary Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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, cefazolin, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04028401


Contacts
Layout table for location contacts
Contact: Stéphane CORVEC 0240083955 ext +33 stephane.corvec@chu-nantes.fr

Locations
Layout table for location information
France
CHU d'Angers Not yet recruiting
Angers, France, 49933
Contact: Laurent HUBERT       LaHubert@chu-angers.fr   
Principal Investigator: Laurent HUBERT         
CHU de Brest Not yet recruiting
Brest, France, 29609
Contact: Dominique LE NEN       dominique.lenen@chu-brest.fr   
Principal Investigator: Dominique LE NEN         
CHU de Nantes Not yet recruiting
Nantes, France, 44093
Contact: Stéphane CORVEC         
Principal Investigator: Marc CAPELLI         
Clinique Saint Michel Sainte Anne Not yet recruiting
Quimper, France, 29000
Contact: Alexandre SONNARD       a.sonnard@orange.fr   
Principal Investigator: Alexandre SONNARD         
CHU de Rennes Not yet recruiting
Rennes, France, 35000
Contact: Hervé HOMAZEAU       herve.thomazeau@chu-rennes.fr   
Principal Investigator: Hervé THOMAZEAU         
Clinique Alliance Not yet recruiting
Saint-Cyr-sur-Loire, France, 37540
Contact: Christophe LE DU       dr.christophe.le.du@gmail.com   
Principal Investigator: Christophe LE DU         
Institut Locomoteur de l'Ouest Not yet recruiting
Saint-Grégoire, France, 35760
Contact: Laurent BAVEREL       l.baverel@gmail.com   
Principal Investigator: Laurent BAVEREL         
Clinique Jeanne d'Arc - Santé Atlantique Not yet recruiting
Saint-Herblain, France, 44819
Contact: Yves BOUJU       yves.bouju@gmail.com   
Principal Investigator: Yves BOUJU         
Polyclinique de l'Atlantique Not yet recruiting
Saint-Herblain, France, 44819
Contact: Mathieu BOISSARD       drboissard@polyclinique-atlantique.fr   
Principal Investigator: Mathieu BOISSARD         
CHU de Tours Not yet recruiting
Tours, France, 37170
Contact: Luc FAVARD       luc.favard@univ-tours.fr   
Principal Investigator: Luc FAVARD         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Stéphane CORVEC CHU de Nantes

Layout table for additonal information
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT04028401     History of Changes
Other Study ID Numbers: RC19_0042
First Posted: July 22, 2019    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Dermatologic Agents