Cutibacterium Acnes: Triple Prevention in Shoulder Operations

NCT05701475 | Completed

• 1 other identifier: 2023C3PO-trial
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Post-Operative Wound Infection; Surgical Site Infection

Keywords

Cutibacterium Acnes; Prevention; Benzoyl peroxide; Subcutaneous disinfection; Surgical site infection; Pre-operative disinfection

Outcome Measures

Primary Outcomes (1)

• Cutibacterium Acnes positivity

  Rate of culture positivity for Cutibacterium Acnes of swabs taken during surgery

  14 days

Secondary Outcomes (2)

• Culture positivity with other bacteria

  14 days

• Adherence to pre-operative protocol

  1 day

Other Outcomes (1)

• Adverse reaction to Benzoyl Peroxide

  1 day

Study Arms (3)

Control/Single prevention

NO INTERVENTION

Standard pre-operative cutaneous disinfection using iodine.

Double prevention

EXPERIMENTAL

Pre-operative cutaneous and subcutaneous disinfection using iodine.

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.

Procedure: Subcutaneous disinfection; Procedure: Benzoyl peroxide preparation

Interventions

Subcutaneous disinfection PROCEDURE

After incision, the subcutaneous tissue will be disinfected for 60 seconds using iodine before continuing the surgical approach.

Double prevention; Triple prevention

Benzoyl peroxide preparation PROCEDURE

In the days prior to surgery, the skin will be prepared using Benzoyl Peroxide gel according to a standardised protocol.

Triple prevention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for all types of surgery at the shoulder joint, acromioclavicular joint, or clavicle, including arthroscopic and open surgery.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Clinique Générale dAnnecy: lead
• Centre Hospitalier Annecy Genevois: collaborator

Study Sites (1)

Clinique Générale d'Annecy

Annecy, France

Location

Related Publications (21)

• 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.

  PMID: 34804207 BACKGROUND

• Moor 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.

  PMID: 33421560 BACKGROUND

• Kaveeshwar 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.

  PMID: 32939469 BACKGROUND

• Hudek 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.

  PMID: 32741563 BACKGROUND

• Lavergne 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.

  PMID: 28065868 BACKGROUND

• Chalmers 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.

  PMID: 31229329 BACKGROUND

• Singh 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.

  PMID: 32197761 BACKGROUND

• Dizay 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.

  PMID: 28479255 BACKGROUND

• Kolakowski 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.

  PMID: 30054245 BACKGROUND

• Sabetta 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.

  PMID: 26067191 BACKGROUND

• Scheer 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.

  PMID: 29609999 BACKGROUND

• van 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.

  PMID: 32197765 BACKGROUND

• Scheer 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.

  PMID: 33545336 BACKGROUND

• Hsu 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.

  PMID: 32385554 BACKGROUND

• Green 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.

  PMID: 36067940 BACKGROUND

• Stull JD, Nicholson TA, Davis DE, Namdari S. Addition of 3% hydrogen peroxide to standard skin preparation reduces Cutibacterium acnes-positive culture rate in shoulder surgery: a prospective randomized controlled trial. J Shoulder Elbow Surg. 2020 Feb;29(2):212-216. doi: 10.1016/j.jse.2019.09.038. Epub 2019 Dec 13.

  PMID: 31839392 BACKGROUND

• Rao AJ, Chalmers PN, Cvetanovich GL, O'Brien MC, Newgren JM, Cole BJ, Verma NN, Nicholson GP, Romeo AA. Preoperative Doxycycline Does Not Reduce Propionibacterium acnes in Shoulder Arthroplasty. J Bone Joint Surg Am. 2018 Jun 6;100(11):958-964. doi: 10.2106/JBJS.17.00584.

  PMID: 29870447 BACKGROUND

• Namdari S, Nicholson T, Parvizi J, Ramsey M. Preoperative doxycycline does not decolonize Propionibacterium acnes from the skin of the shoulder: a randomized controlled trial. J Shoulder Elbow Surg. 2017 Sep;26(9):1495-1499. doi: 10.1016/j.jse.2017.06.039. Epub 2017 Jul 19.

  PMID: 28734717 BACKGROUND

• Matsen FA, Whitson AJ, Hsu JE. While home chlorhexidine washes prior to shoulder surgery lower skin loads of most bacteria, they are not effective against Cutibacterium (Propionibacterium). Int Orthop. 2020 Mar;44(3):531-534. doi: 10.1007/s00264-019-04477-w. Epub 2020 Jan 14.

  PMID: 31938858 BACKGROUND

• MacLean SBM, Phadnis J, Ling CM, Bain GI. Application of dermal chlorhexidine antisepsis is ineffective at reducing Proprionibacterium acnes colonization in shoulder surgery. Shoulder Elbow. 2019 Apr;11(2):98-105. doi: 10.1177/1758573218755570. Epub 2018 Jan 30.

  PMID: 30936948 BACKGROUND

• Duvall G, Kaveeshwar S, Sood A, Klein A, Williams K, Kolakowski L, Lai J, Enobun B, Hasan SA, Henn RF 3rd, Gilotra MN. Benzoyl peroxide use transiently decreases Cutibacterium acnes load on the shoulder. J Shoulder Elbow Surg. 2020 Apr;29(4):794-798. doi: 10.1016/j.jse.2019.06.026. Epub 2019 Oct 31.

  PMID: 31676186 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Geert A Buijze, MD, PhD

  Clinique Générale d'Annecy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Since the disinfection protocol has to be performed by the patient and care provider, this can not be blinded. However, the laboratory staff will not know which treatment arm the patient was allocated to when assessing the bacterial cultures.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 27, 2023
• Study Start: January 18, 2023
• Primary Completion: December 28, 2024
• Study Completion: December 28, 2024
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)