Optimization of skin preparation to reduce Cutibacterium acnes colonization in superficial and deep samples during prosthetic shoulder surgery in male patients

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Nantes

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

19 Jun 2020 → ongoing

Decision date (initial)

2024-10-21

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-515584-56-00

EudraCT number

2019-001419-21

ClinicalTrials.gov

NCT04028401

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Prophylaxis

Evaluate the efficacy of daily application, during the 5 days preceding the procedure, of a 5% benzoyl peroxide topical treatment in the surgical skin incision area, on the reduction of Cutibacterium acnes bacterial load in the dermis of the approach to shoulder arthroplasty in men.

Secondary objectives 4

1. Evaluate, in the context of shoulder arthroplasty in men, the effectiveness of applying 5% benzoyl peroxide to the skin incision area during the 5 days preceding the operation, on: the bacterial load of Cutibacterium acnes on the skin, fat and capsular level; incidence of Cutibacterium acnes infections within 2 years of surgery
2. Evaluate, in the context of a shoulder arthroplasty in humans, the efficacy of alcoholic iodine povidone 5% (antiseptic from the operating area to the operating room) on the cutaneous bacterial load with Cutibacterium acnes
3. Characterize the different strains of Cutibacterium acnes found at the phylotypic and genotypic level
4. Evaluate the skin tolerance of the application of 5% benzoyl peroxide gel

Conditions and MedDRA coding

Cutibacterium acnes infection in shoulder arthroplasty with males

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Male patients
2. Adult patients
3. Patient without a history of surgical intervention on the operated shoulder
4. 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
5. Patients affiliated to a social security system
6. Patients who have given their informed and written consent

Exclusion criteria 13

1. Patient with arthroplasty for resumption of previous shoulder surgery or failure of arthroplasty
2. Major under guardianship
3. Patient under the protection of justice
4. Patient not covered by social security
5. Patient with arthroplasty for acute trauma
6. Patient on immunosuppressive drugs
7. Patient with inflammatory rheumatism
8. Patient with progressive cancer pathology
9. Allergies or intolerances concerning the modalities of selected skin preparations (Povidone Iodine, hypersensitivity to benzoyl peroxide)
10. Dermatological pathologies in the area to be treated
11. Acne treatment in the area to be treated within four weeks before inclusion
12. Patient without possible help from a third party for the application of Cutacnyl® 5% in the intervention group if necessary
13. patient with an infectious site

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Number of patients in each group (interventional: benzoyl peroxide 5% for 5 days or control) with a positive Cutibacterium acnes sample at the dermis.

Secondary endpoints 5

1. Average number of positive intraoperative Cutibacterium acnes samples taken at the cutaneous level before and after cutaneous antisepsis of the operating area before incision, fat and capsular. The skin sample at inclusion will allow the initial cutaneous Cutibacterium acnes bacterial load to be compared between both groups
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
3. Incidence of Cutibacterium acnes shoulder prosthesis infections up to 2 years after shoulder prosthesis implantation in both study groups
4. Determination of phylotype, 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. Evaluation of the skin tolerance of the topical application from the local tolerance scale (irritation, erythema and desquamation), at the time of inclusion and at D0

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Nantes

Sponsor organisation

Centre Hospitalier Universitaire De Nantes

Address

5 Allee De L Ile Gloriette, Cs 69301 Cs 69301

City

Nantes Cedex 1

Postcode

44093

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Nantes

Contact name

Stéphane CORVEC

Public contact point

Organisation

Centre Hospitalier Universitaire De Nantes

Contact name

Stéphane CORVEC

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications