Post-Operative Wound InfectionC3PONCT05701475
Cutibacterium Acnes: Triple Prevention in Shoulder Operations
A study testing Subcutaneous disinfection and Benzoyl peroxide preparation in people with Post-Operative Wound Infection and Surgical Site Infection, run by Clinique Générale dAnnecy at 1 site in France.
Trial summary
Patients planned for shoulder surgery will be identified and contacted for participation. After informed consent is provided, patients will be randomised into one of three groups: pre-operative cutaneous disinfection with iodine (control group), pre-operative cutaneous and subcutaneous disinfection with iodine (double… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Operative Wound Infection, Surgical Site Infection
- What is being tested?
- Subcutaneous disinfection and Benzoyl peroxide preparation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jan 2023to 28 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for all types of surgery at the shoulder joint, acromioclavicular joint, or clavicle, including arthroscopic and open surgery.
Who cannot join
- Previous shoulder surgery;
- History of shoulder infection;
- Antibiotic treatment in the last 6 weeks;
- Allergy or hypersensitivity to one of the disinfecting agents;
- Patients with laboratory values consistent with a current infection (C-reactive protein, erythrocyte sedimentation rate, leukocyte count).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Triple Prevention Against Cutibacterium Acnes Using Benzoyl Peroxide Preparation in Addition to Pre-operative Cutaneous and Subcutaneous Iodine in Shoulder Surgery; a Single-blinded, Randomized, Controlled Trial.
Patients planned for shoulder surgery will be identified and contacted for participation. After informed consent is provided, patients will be randomised into one of three groups: pre-operative cutaneous disinfection with iodine (control group), pre-operative cutaneous and subcutaneous disinfection with iodine (double prevention), and pre-operative cutaneous and subcutaneous disinfection with iodine combined with a skin preparation protocol with benzoyl peroxide gel in the days prior to surgery (triple prevention). Bacterial cultures will be collected during surgery of the surgical field and tissue layers. Culture positivity for Cutibacterium Acnes will be compared between the groups as a primary outcome.
Read the detailed description
Eligible patients will be contacted for participation (see Eligibility Criteria). If subjects meet the inclusion criteria, patients will receive information regarding the study outline, associated risks, and subject rights. Informed consent must be freely given, specific, unambiguous, and may be withdrawn at any time. Subjects must be legally capable of providing consent. Consent will be and recorded in writing and stored for the duration of the study. The target for inclusion was set at 52 patients in each group, of each group 26 will be arthroscopic and 26 open surgery.
Patients will be divided into three groups of equal size:
- Triple-prevention: Benzoyl peroxide at home, subcutaneous iodine, and cutaneous iodine.
- Double-prevention: Cutaneous and subcutaneous iodine.
- Single-prevention (control group): cutaneous iodine.
Simple block randomisation will be used to prevent chronological bias and ensure equal group size. Treatments will be allocated with a 1:1:1 ratio using a block size of 12. Randomisation will be stratified by open or arthroscopic surgery to ensure an equal number in all three groups (3x2x26 patients) Random treatment allocation numbers will be generated and blinded, to be revealed after inclusion.
Benzoyl peroxide:
Patients will be instructed to apply and rub in a 5-cm strip of 5% benzoyl peroxide gel to the shoulder on dry skin in the morning and evening 2 days prior to surgery, 1 day before surgery, and a fifth time in the morning on the day of surgery.
Cutaneous iodine:
Standard pre-operative preparation including cutaneous disinfection with alcoholic iodine, sterile drapes.
Subcutaneous iodine:
Open surgery: after incision down to the fascia of the muscle layer, preparation of the whole subcutaneous layer with povidone-iodine solution will be performed and left acting during 60 seconds before full aspiration and lavage in order to not have swabs drained in povidone-iode (as it could continue to act as antiseptic during culture).
For arthroscopic procedures the disinfection and swab collection protocol will be performed when creating the first portal.
Bacterial culture swabs (n=9) will be taken during surgery from the patients' skin (before disinfection with iodine), subcutaneous tissue (after disinfection if randomised for subcutaneous disinfection), muscular layer, intra-articular/layer of the intervention (for example in case of clavicle surgery from the clavicle), surgeon's glove, outside scalpel, inside scalpel, and the retractors. For the swabs in the operative field, the applicable field is to be swabbed fully for 3 seconds. Each surgeon will follow the clear swab instructions from the microbiologist in order to obtain reliable cultures. Cultures will be analysed by the hospital's medical microbiological laboratory following standard protocol including a standard incubation time of 14 days. Treatment arm will be blinded for the laboratory employees.
Culture positivity between the groups will be analysed using chi-square tests for each culture location. In addition, a two-way ANOVA test will be performed to assess total number of positive cultures per patient. Furthermore, logistic regression models will be used to adjust for several potential confounding factors depending on the number of positive tests in the sample.
- Being tested
- Subcutaneous disinfection, Benzoyl peroxide preparation
- Keywords
- Cutibacterium Acnes, Prevention, Benzoyl peroxide, Subcutaneous disinfection, Surgical site infection, Pre-operative disinfection
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous disinfectionProcedure or surgery
After incision, the subcutaneous tissue will be disinfected for 60 seconds using iodine before continuing the surgical approach.
Benzoyl peroxide preparationProcedure or surgery
In the days prior to surgery, the skin will be prepared using Benzoyl Peroxide gel according to a standardised protocol.
| Study group | Role | What they receive |
|---|---|---|
| Control/Single prevention | No intervention | Standard pre-operative cutaneous disinfection using iodine. |
| Double prevention | Experimental | Pre-operative cutaneous and subcutaneous disinfection using iodine. Receives: Procedure: Subcutaneous disinfection |
| Triple prevention | Experimental | Pre-operative cutaneous and subcutaneous disinfection using iodine and preparation of the skin with benzoyl peroxide in the days prior to surgery. Receives: Procedure: Subcutaneous disinfection; Procedure: Benzoyl peroxide preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutibacterium Acnes positivity
Rate of culture positivity for Cutibacterium Acnes of swabs taken during surgery
Measured: 14 days
Secondary outcomes (2)
Culture positivity with other bacteria
Rate of culture positivity for other types of bacteria of swabs taken during surgery
Measured: 14 days
Adherence to pre-operative protocol
Completeness percentage of the pre-operative skin preparation protocol as reported by participants the morning of the intervention
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start18 Jan 2023
- Primary completion28 Dec 2024
- Study completion28 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Post-Operative Wound InfectionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Générale dAnnecy
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Annecy Genevois
- Responsible party
- Sponsor
- Investigators
- Geert A Buijze, MD, PhD, Principal investigator, Clinique Générale d'Annecy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701475
- Sponsor's protocol ID
- 2023C3PO-trial
- Acronym
- C3PO
- Status last verified
- Nov 2025
- First submitted
- 18 Jan 2023
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moore NF, Batten TJ, Hutton CE, White WJ, Smith CD. The management of the shoulder skin microbiome (Cutibacterium acnes) in the context of shoulder surgery: a review of the current literature. Shoulder Elbow. 2021 Oct;13(6):592-599. doi: 10.1177/1758573220945226. Epub 2020 Jul 27.
PubMed 34804207Moor BK, Leger B, Steffen V, Troillet N, Emonet S, Gallusser N. Subcutaneous tissue disinfection significantly reduces Cutibacterium acnes burden in primary open shoulder surgery. J Shoulder Elbow Surg. 2021 Jul;30(7):1537-1543. doi: 10.1016/j.jse.2020.11.018. Epub 2021 Jan 6.
PubMed 33421560Kaveeshwar S, Duvall G, Jones DL, O'Hara NN, Klein A, Diedrich AM, Kolakowski L, Lai JK, Hasan SA, Henn RF 3rd, Gilotra MN. Risk factors for increased shoulder Cutibacterium acnes burden. JSES Int. 2020 Jun 3;4(3):464-469. doi: 10.1016/j.jseint.2020.04.020. eCollection 2020 Sep.
PubMed 32939469Hudek R, Brobeil A, Bruggemann H, Sommer F, Gattenlohner S, Gohlke F. Cutibacterium acnes is an intracellular and intra-articular commensal of the human shoulder joint. J Shoulder Elbow Surg. 2021 Jan;30(1):16-26. doi: 10.1016/j.jse.2020.04.020. Epub 2020 Jun 9.
PubMed 32741563Lavergne V, Malo M, Gaudelli C, Laprade M, Leduc S, Laflamme P, Rouleau DM. Clinical impact of positive Propionibacterium acnes cultures in orthopedic surgery. Orthop Traumatol Surg Res. 2017 Apr;103(2):307-314. doi: 10.1016/j.otsr.2016.12.005. Epub 2017 Jan 5.
PubMed 28065868Chalmers PN, Beck L, Stertz I, Tashjian RZ. Hydrogen peroxide skin preparation reduces Cutibacterium acnes in shoulder arthroplasty: a prospective, blinded, controlled trial. J Shoulder Elbow Surg. 2019 Aug;28(8):1554-1561. doi: 10.1016/j.jse.2019.03.038. Epub 2019 Jun 20.
PubMed 31229329Singh AM, Sethi PM, Romeo AA, Anakwenze OA, Abboud JA, Namdari S. Strategies to decolonize the shoulder of Cutibacterium acnes: a review of the literature. J Shoulder Elbow Surg. 2020 Apr;29(4):660-666. doi: 10.1016/j.jse.2019.11.037.
PubMed 32197761Dizay HH, Lau DG, Nottage WM. Benzoyl peroxide and clindamycin topical skin preparation decreases Propionibacterium acnes colonization in shoulder arthroscopy. J Shoulder Elbow Surg. 2017 Jul;26(7):1190-1195. doi: 10.1016/j.jse.2017.03.003. Epub 2017 May 4.
PubMed 28479255Kolakowski L, Lai JK, Duvall GT, Jauregui JJ, Dubina AG, Jones DL, Williams KM, Hasan SA, Henn RF 3rd, Gilotra MN. Neer Award 2018: Benzoyl peroxide effectively decreases preoperative Cutibacterium acnes shoulder burden: a prospective randomized controlled trial. J Shoulder Elbow Surg. 2018 Sep;27(9):1539-1544. doi: 10.1016/j.jse.2018.06.012. Epub 2018 Jul 24.
PubMed 30054245Sabetta JR, Rana VP, Vadasdi KB, Greene RT, Cunningham JG, Miller SR, Sethi PM. Efficacy of topical benzoyl peroxide on the reduction of Propionibacterium acnes during shoulder surgery. J Shoulder Elbow Surg. 2015 Jul;24(7):995-1004. doi: 10.1016/j.jse.2015.04.003.
PubMed 26067191Scheer VM, Bergman Jungestrom M, Lerm M, Serrander L, Kalen A. Topical benzoyl peroxide application on the shoulder reduces Propionibacterium acnes: a randomized study. J Shoulder Elbow Surg. 2018 Jun;27(6):957-961. doi: 10.1016/j.jse.2018.02.038. Epub 2018 Mar 30.
PubMed 29609999van Diek FM, Pruijn N, Spijkers KM, Mulder B, Kosse NM, Dorrestijn O. The presence of Cutibacterium acnes on the skin of the shoulder after the use of benzoyl peroxide: a placebo-controlled, double-blinded, randomized trial. J Shoulder Elbow Surg. 2020 Apr;29(4):768-774. doi: 10.1016/j.jse.2019.11.027.
PubMed 32197765Scheer VM, Jungestrom MB, Serrander L, Kalen A, Scheer JH. Benzoyl peroxide treatment decreases Cutibacterium acnes in shoulder surgery, from skin incision until wound closure. J Shoulder Elbow Surg. 2021 Jun;30(6):1316-1323. doi: 10.1016/j.jse.2020.12.019. Epub 2021 Feb 3.
PubMed 33545336Hsu JE, Whitson AJ, Woodhead BM, Napierala MA, Gong D, Matsen FA 3rd. Randomized controlled trial of chlorhexidine wash versus benzoyl peroxide soap for home surgical preparation: neither is effective in removing Cutibacterium from the skin of shoulder arthroplasty patients. Int Orthop. 2020 Jul;44(7):1325-1329. doi: 10.1007/s00264-020-04594-x. Epub 2020 May 8.
PubMed 32385554Green N, Jordan RW, Maclean S, D'Alessandro P, MacDonald PB, Malik SS. Preoperative topical benzoyl peroxide treatment is effective in reducing Cutibacterium acnes in shoulder surgery: a systematic review. J Shoulder Elbow Surg. 2023 Jan;32(1):213-222. doi: 10.1016/j.jse.2022.07.019. Epub 2022 Sep 5.
PubMed 36067940
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple Prevention Against Cutibacterium Acnes Using Benzoyl Peroxide Preparation in Addition to Pre-operative Cutaneous and Subcutaneous Iodine in Shoulder Surgery; a Single-blinded, Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT05701475
- Acronym / sponsor ID
- C3PO / 2023C3PO-trial
- Keywords
- Cutibacterium Acnes, Prevention, Benzoyl peroxide, Subcutaneous disinfection, Surgical site infection, Pre-operative disinfection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Clinique Générale dAnnecyUniversity, hospital or other
- Collaborators
- Centre Hospitalier Annecy Genevois
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 28 Dec 2024 (actual)
- Study completion
- 28 Dec 2024 (actual)
- First posted
- 27 Jan 2023 (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.
Patients planned for shoulder surgery will be identified and contacted for participation. After informed consent is provided, patients will be randomised into one of three groups: pre-operative cutaneous disinfection with iodine (control group), pre-operative cutaneous and subcutaneous disinfection with iodine (double prevention), and pre-operative cutaneous and subcutaneous disinfection with iodine combined with a skin preparation protocol with benzoyl peroxide gel in the days prior to surgery (triple prevention). Bacterial cultures will be collected during surgery of the surgical field and tissue layers. Culture positivity for Cutibacterium Acnes will be compared between the groups as a primary outcome.
Detailed description
Eligible patients will be contacted for participation (see Eligibility Criteria). If subjects meet the inclusion criteria, patients will receive information regarding the study outline, associated risks, and subject rights. Informed consent must be freely given, specific, unambiguous, and may be withdrawn at any time. Subjects must be legally capable of providing consent. Consent will be and recorded in writing and stored for the duration of the study. The target for inclusion was set at 52 patients in each group, of each group 26 will be arthroscopic and 26 open surgery.
Patients will be divided into three groups of equal size:
- Triple-prevention: Benzoyl peroxide at home, subcutaneous iodine, and cutaneous iodine.
- Double-prevention: Cutaneous and subcutaneous iodine.
- Single-prevention (control group): cutaneous iodine.
Simple block randomisation will be used to prevent chronological bias and ensure equal group size. Treatments will be allocated with a 1:1:1 ratio using a block size of 12. Randomisation will be stratified by open or arthroscopic surgery to ensure an equal number in all three groups (3x2x26 patients) Random treatment allocation numbers will be generated and blinded, to be revealed after inclusion.
Benzoyl peroxide:
Patients will be instructed to apply and rub in a 5-cm strip of 5% benzoyl peroxide gel to the shoulder on dry skin in the morning and evening 2 days prior to surgery, 1 day before surgery, and a fifth time in the morning on the day of surgery.
Cutaneous iodine:
Standard pre-operative preparation including cutaneous disinfection with alcoholic iodine, sterile drapes.
Subcutaneous iodine:
Open surgery: after incision down to the fascia of the muscle layer, preparation of the whole subcutaneous layer with povidone-iodine solution will be performed and left acting during 60 seconds before full aspiration and lavage in order to not have swabs drained in povidone-iode (as it could continue to act as antiseptic during culture).
For arthroscopic procedures the disinfection and swab collection protocol will be performed when creating the first portal.
Bacterial culture swabs (n=9) will be taken during surgery from the patients' skin (before disinfection with iodine), subcutaneous tissue (after disinfection if randomised for subcutaneous disinfection), muscular layer, intra-articular/layer of the intervention (for example in case of clavicle surgery from the clavicle), surgeon's glove, outside scalpel, inside scalpel, and the retractors. For the swabs in the operative field, the applicable field is to be swabbed fully for 3 seconds. Each surgeon will follow the clear swab instructions from the microbiologist in order to obtain reliable cultures. Cultures will be analysed by the hospital's medical microbiological laboratory following standard protocol including a standard incubation time of 14 days. Treatment arm will be blinded for the laboratory employees.
Culture positivity between the groups will be analysed using chi-square tests for each culture location. In addition, a two-way ANOVA test will be performed to assess total number of positive cultures per patient. Furthermore, logistic regression models will be used to adjust for several potential confounding factors depending on the number of positive tests in the sample.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control/Single prevention | No intervention | –Standard pre-operative cutaneous disinfection using iodine. |
| Double prevention | Experimental | Procedure: Subcutaneous disinfectionPre-operative cutaneous and subcutaneous disinfection using iodine. |
| Triple prevention | Experimental | Procedure: Subcutaneous disinfection, Procedure: Benzoyl peroxide preparationPre-operative cutaneous and subcutaneous disinfection using iodine and preparation of the skin with benzoyl peroxide in the days prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Indication for all types of surgery at the shoulder joint, acromioclavicular joint, or clavicle, including arthroscopic and open surgery.
Key exclusion criteria (5 listed)
- Previous shoulder surgery;
- History of shoulder infection;
- Antibiotic treatment in the last 6 weeks;
- Allergy or hypersensitivity to one of the disinfecting agents;
- Patients with laboratory values consistent with a current infection (C-reactive protein, erythrocyte sedimentation rate, leukocyte count).
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 |
|---|---|---|
| Subcutaneous disinfectionAfter incision, the subcutaneous tissue will be disinfected for 60 seconds using iodine before continuing the surgical approach. | Procedure or surgery | Double prevention, Triple prevention |
| Benzoyl peroxide preparationIn the days prior to surgery, the skin will be prepared using Benzoyl Peroxide gel according to a standardised protocol. | Procedure or surgery | Triple prevention |
Primary outcome
Cutibacterium Acnes positivity
Time frame: 14 days
Rate of culture positivity for Cutibacterium Acnes of swabs taken during surgery
2 secondary outcomes
Culture positivity with other bacteria
Time frame: 14 days
Adherence to pre-operative protocol
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Background: PubMed 34804207Moore NF, Batten TJ, Hutton CE, White WJ, Smith CD. The management of the shoulder skin microbiome (Cutibacterium acnes) in the context of shoulder surgery: a review of the current literature. Shoulder Elbow. 2021 Oct;13(6):592-599. doi: 10.1177/1758573220945226. Epub 2020 Jul 27.
- Background: PubMed 33421560Moor BK, Leger B, Steffen V, Troillet N, Emonet S, Gallusser N. Subcutaneous tissue disinfection significantly reduces Cutibacterium acnes burden in primary open shoulder surgery. J Shoulder Elbow Surg. 2021 Jul;30(7):1537-1543. doi: 10.1016/j.jse.2020.11.018. Epub 2021 Jan 6.
- Background: PubMed 32939469Kaveeshwar S, Duvall G, Jones DL, O'Hara NN, Klein A, Diedrich AM, Kolakowski L, Lai JK, Hasan SA, Henn RF 3rd, Gilotra MN. Risk factors for increased shoulder Cutibacterium acnes burden. JSES Int. 2020 Jun 3;4(3):464-469. doi: 10.1016/j.jseint.2020.04.020. eCollection 2020 Sep.
- Background: PubMed 32741563Hudek R, Brobeil A, Bruggemann H, Sommer F, Gattenlohner S, Gohlke F. Cutibacterium acnes is an intracellular and intra-articular commensal of the human shoulder joint. J Shoulder Elbow Surg. 2021 Jan;30(1):16-26. doi: 10.1016/j.jse.2020.04.020. Epub 2020 Jun 9.
- Background: PubMed 28065868Lavergne V, Malo M, Gaudelli C, Laprade M, Leduc S, Laflamme P, Rouleau DM. Clinical impact of positive Propionibacterium acnes cultures in orthopedic surgery. Orthop Traumatol Surg Res. 2017 Apr;103(2):307-314. doi: 10.1016/j.otsr.2016.12.005. Epub 2017 Jan 5.
- Background: PubMed 31229329Chalmers PN, Beck L, Stertz I, Tashjian RZ. Hydrogen peroxide skin preparation reduces Cutibacterium acnes in shoulder arthroplasty: a prospective, blinded, controlled trial. J Shoulder Elbow Surg. 2019 Aug;28(8):1554-1561. doi: 10.1016/j.jse.2019.03.038. Epub 2019 Jun 20.
- Background: PubMed 32197761Singh AM, Sethi PM, Romeo AA, Anakwenze OA, Abboud JA, Namdari S. Strategies to decolonize the shoulder of Cutibacterium acnes: a review of the literature. J Shoulder Elbow Surg. 2020 Apr;29(4):660-666. doi: 10.1016/j.jse.2019.11.037.
- Background: PubMed 28479255Dizay HH, Lau DG, Nottage WM. Benzoyl peroxide and clindamycin topical skin preparation decreases Propionibacterium acnes colonization in shoulder arthroscopy. J Shoulder Elbow Surg. 2017 Jul;26(7):1190-1195. doi: 10.1016/j.jse.2017.03.003. Epub 2017 May 4.
- Background: PubMed 30054245Kolakowski L, Lai JK, Duvall GT, Jauregui JJ, Dubina AG, Jones DL, Williams KM, Hasan SA, Henn RF 3rd, Gilotra MN. Neer Award 2018: Benzoyl peroxide effectively decreases preoperative Cutibacterium acnes shoulder burden: a prospective randomized controlled trial. J Shoulder Elbow Surg. 2018 Sep;27(9):1539-1544. doi: 10.1016/j.jse.2018.06.012. Epub 2018 Jul 24.
- Background: PubMed 26067191Sabetta JR, Rana VP, Vadasdi KB, Greene RT, Cunningham JG, Miller SR, Sethi PM. Efficacy of topical benzoyl peroxide on the reduction of Propionibacterium acnes during shoulder surgery. J Shoulder Elbow Surg. 2015 Jul;24(7):995-1004. doi: 10.1016/j.jse.2015.04.003.
- Background: PubMed 29609999Scheer VM, Bergman Jungestrom M, Lerm M, Serrander L, Kalen A. Topical benzoyl peroxide application on the shoulder reduces Propionibacterium acnes: a randomized study. J Shoulder Elbow Surg. 2018 Jun;27(6):957-961. doi: 10.1016/j.jse.2018.02.038. Epub 2018 Mar 30.
- Background: PubMed 32197765van Diek FM, Pruijn N, Spijkers KM, Mulder B, Kosse NM, Dorrestijn O. The presence of Cutibacterium acnes on the skin of the shoulder after the use of benzoyl peroxide: a placebo-controlled, double-blinded, randomized trial. J Shoulder Elbow Surg. 2020 Apr;29(4):768-774. doi: 10.1016/j.jse.2019.11.027.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Geert A Buijze, MD, PhD principal investigator
Clinique Générale d'Annecy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous disinfection and Benzoyl peroxide preparation in people with Post-Operative Wound Infection and Surgical Site Infection, run by Clinique Générale dAnnecy at 1 site 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cutibacterium Acnes positivity (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05701475, which also lists 21 linked publications.
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 4 Dec 2025.