Cutibacterium Acnes InfectionPhase 3OPRICANCT04028401
Optimization of Skin Preparation to Reduce Cutibacterium Acnes Colonization in Superficial and Deep Samples During Prosthetic Shoulder Surgery in Male Patients
A Phase 3 study testing 5% benzoyl peroxide in people with Cutibacterium Acnes Infection, run by Nantes University Hospital at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cutibacterium Acnes Infection
- What is being tested?
- 5% benzoyl peroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 6 sitesFrance
- Study dates
- 19 Jun 2020to Jun 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
CHU d'Angers
Angers, 49933
Laurent HUBERT, LaHubert@chu-angers.fr
Laurent HUBERT
- Recruiting
CHU de Brest
Brest, 29609
Hoel LETISSIER, hoel.letissier@chu-brest.fr
Hoel LETISSIER
- Recruiting
CHU de Limoges
Limoges, 87000
Pierre Sylvain MARCHEIX, Pr, 0555056771, pierre-sylvain.marcheix@chu-limoges.fr
Pierre Sylvain MARCHEIX, Pr
- Recruiting
CHU de Nantes
Nantes, 44093
Stéphane CORVEC
Marc CAPELLI
- Recruiting
CHU de Rennes
Rennes, 35000
Hervé THOMAZEAU, herve.thomazeau@chu-rennes.fr
Hervé THOMAZEAU
- Recruiting
CHU de Tours
Tours, 37170
Luc FAVARD, luc.favard@univ-tours.fr
Luc FAVARD
About this study
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.
- Conditions
- Cutibacterium Acnes Infection
- Being tested
- 5% benzoyl peroxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% benzoyl peroxideDrug
Application of 5% benzoyl peroxide during 5 days before the procedure
| Study group | Role | What they receive |
|---|---|---|
| 5 % benzoyl peroxide topical treatment | Experimental | Application of 5% benzoyl peroxide Receives: Drug: 5% benzoyl peroxide |
| No topical treatment | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients in each group with a positive Cutibacterium acnes sample at the dermis.
Measured: Day 0
Secondary outcomes (7)
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.
Measured: 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
Measured: Day 0
Incidence of Cutibacterium acnes shoulder prosthesis infections up to 2 years after shoulder prosthesis implantation in both study groups
Measured: 2 years
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
Measured: Day 0
Cutibacterium acnes strains
Comparison of Cutibacterium acnes strains by molecular biology
Measured: Day 0
Antibiotic resistance
Measured: 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
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)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start19 Jun 2020
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutibacterium Acnes InfectionStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane CORVEC, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028401
- Sponsor's protocol ID
- RC19_0042
- Acronym
- OPRICA
- Status last verified
- Apr 2025
- First submitted
- 17 Jul 2019
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Skin Preparation to Reduce Cutibacterium Acnes Colonization in Superficial and Deep Samples During Prosthetic Shoulder Surgery in Male Patients
- ClinicalTrials.gov ID
- NCT04028401
- Acronym / sponsor ID
- OPRICA / RC19_0042
- Conditions
- Cutibacterium Acnes Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 22 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 % benzoyl peroxide topical treatment | Experimental | Drug: 5% benzoyl peroxideApplication of 5% benzoyl peroxide |
| No topical treatment | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5% benzoyl peroxideApplication of 5% benzoyl peroxide during 5 days before the procedure | Drug | 5 % benzoyl peroxide topical treatment |
Primary outcome
Number of patients in each group with a positive Cutibacterium acnes sample at the dermis.
Time frame: Day 0
7 secondary outcomes
Average number of positive intraoperative Cutibacterium acnes samples
Time frame: 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
Incidence of Cutibacterium acnes shoulder prosthesis infections up to 2 years after shoulder prosthesis implantation in both study groups
Time frame: 2 years
Phylotype
Time frame: Day 0
Cutibacterium acnes strains
Time frame: Day 0
Antibiotic resistance
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: No
Related trials for Cutibacterium Acnes Infection
Not yet recruitingPhase 4
Finasteride and Cutibacterium
Dihydrotestosterone, Periprosthetic Joint Infection (PJI)
RecruitingPhase 3
Impact of Rifampicin in Treatment Outcome of Cutibacterium Acnes Prosthetic Joint Infections
Infections Joint Prosthetic
Recruiting
Antimicrobial Prophylaxis for Skin Colonization With Propionibacterium Acnes in Primary Open Shoulder Surgery
Propionibacterium Infection
Recruiting
Reduction of Bacterial Seeding in Total Shoulder Arthroplasty
Joint Arthroplasty, Shoulder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stéphane CORVEC principal investigator
Nantes University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5% benzoyl peroxide in people with Cutibacterium Acnes Infection, run by Nantes University Hospital at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphane CORVEC (0240083955 ext. +33, stephane.corvec@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients in each group with a positive Cutibacterium acnes sample at the dermis. (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.