Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
126 participants
INTERVENTIONAL
2024-03-20
2027-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of Surgical Diathermy in Eradicating Cutibacterium Acnes From Surgical Skin Incision During Shoulder Arthroplasty
NCT04608916
Preoperative Jumpstart for Decolonization of P. Acnes
NCT03466658
Acne Face Wash for Reducing the Contamination Rate in Arthroscopic Rotator Cuff Repair Surgery
NCT07239349
Open Versus Arthroscopic Assisted Treatment of Acute Acromioclavicular Joint Disruption Using Suture Button Device
NCT06019260
Optimizing Infection Prophylaxis Prior to Shoulder Surgery
NCT06464770
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Normal Saline Irrigation Arm (Group 1)
After deep dissection, and prior to implantation of components, 100 cc of normal saline will be irrigated into the deep wound and progress outward through more superficial planes to the skin. Cultures will then be taken at multiple wound depths and time points.
Saline Irrigation Solution Delivery
Normal saline is isotonic and the most commonly used wound irrigation solution due to safety (lowest toxicity) and physiologic factors.
Irrisept irrigation Arm (Group 2)
After deep dissection, and prior to implantation of components, 100 cc of Irrisept solution will be irrigated into the deep wound and progress outward through more superficial planes to the skin. Cultures will then be taken at multiple wound depths and time points.
Irrisept Irrigation
Irrisept Antimicrobial Wound Lavage is a single-use, manual, self-contained irrigation device. Irrisept contains 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United Staes Pharmacopeia (USP). The solution is aseptically filled in a Blow-Fill-Seal (BFS) bottle.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Irrisept Irrigation
Irrisept Antimicrobial Wound Lavage is a single-use, manual, self-contained irrigation device. Irrisept contains 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United Staes Pharmacopeia (USP). The solution is aseptically filled in a Blow-Fill-Seal (BFS) bottle.
Saline Irrigation Solution Delivery
Normal saline is isotonic and the most commonly used wound irrigation solution due to safety (lowest toxicity) and physiologic factors.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* History of shoulder infection
* Antibiotic therapy within 2 weeks of surgery
* Cortisone infiltration within 3 months prior to surgery
* Allergy to CHG
* Diagnosis of rheumatoid arthritis
* Immunocompromised patients
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Irrimax Corporation
INDUSTRY
Orthopaedic Education and Research Institute (dba Hoag Orthopedics)
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hafiz F Kassam, MD
Role: PRINCIPAL_INVESTIGATOR
Hoag Orthopedics Education and Research
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hoag Orthopedics
Orange, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Athwal GS, Sperling JW, Rispoli DM, Cofield RH. Deep infection after rotator cuff repair. J Shoulder Elbow Surg. 2007 May-Jun;16(3):306-11. doi: 10.1016/j.jse.2006.05.013. Epub 2007 Feb 22.
Horneff JG 3rd, Hsu JE, Voleti PB, O'Donnell J, Huffman GR. Propionibacterium acnes infection in shoulder arthroscopy patients with postoperative pain. J Shoulder Elbow Surg. 2015 Jun;24(6):838-43. doi: 10.1016/j.jse.2015.03.008.
Foster AL, Cutbush K, Ezure Y, Schuetz MA, Crawford R, Paterson DL. Cutibacterium acnes in shoulder surgery: a scoping review of strategies for prevention, diagnosis, and treatment. J Shoulder Elbow Surg. 2021 Jun;30(6):1410-1422. doi: 10.1016/j.jse.2020.11.011. Epub 2020 Dec 26.
Chuang MJ, Jancosko JJ, Mendoza V, Nottage WM. The Incidence of Propionibacterium acnes in Shoulder Arthroscopy. Arthroscopy. 2015 Sep;31(9):1702-7. doi: 10.1016/j.arthro.2015.01.029. Epub 2015 Mar 29.
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.
Millett PJ, Yen YM, Price CS, Horan MP, van der Meijden OA, Elser F. Propionibacterium acnes infection as an occult cause of postoperative shoulder pain: a case series. Clin Orthop Relat Res. 2011 Oct;469(10):2824-30. doi: 10.1007/s11999-011-1767-4. Epub 2011 Jan 15.
Contreras ES, Frantz TL, Bishop JY, Cvetanovich GL. Periprosthetic Infection After Reverse Shoulder Arthroplasty: a Review. Curr Rev Musculoskelet Med. 2020 Dec;13(6):757-768. doi: 10.1007/s12178-020-09670-8.
Cooper ME, Trivedi NN, Sivasundaram L, Karns MR, Voos JE, Gillespie RJ. Diagnosis and Management of Periprosthetic Joint Infection After Shoulder Arthroplasty. JBJS Rev. 2019 Jul;7(7):e3. doi: 10.2106/JBJS.RVW.18.00152. No abstract available.
Lemmens L, Geelen H, Depypere M, De Munter P, Verhaegen F, Zimmerli W, Nijs S, Debeer P, Metsemakers WJ. Management of periprosthetic infection after reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2021 Nov;30(11):2514-2522. doi: 10.1016/j.jse.2021.04.014. Epub 2021 Apr 22.
Horneff JG, Hsu JE, Huffman GR. Propionibacterium acnes infections in shoulder surgery. Orthop Clin North Am. 2014 Oct;45(4):515-21. doi: 10.1016/j.ocl.2014.06.004. Epub 2014 Jul 11.
Heckmann N, Heidari KS, Jalali O, Weber AE, She R, Omid R, Vangsness CT, Rick Hatch GF 3rd. Cutibacterium acnes persists despite topical clindamycin and benzoyl peroxide. J Shoulder Elbow Surg. 2019 Dec;28(12):2279-2283. doi: 10.1016/j.jse.2019.06.016. Epub 2019 Aug 27.
Phadnis J, Gordon D, Krishnan J, Bain GI. Frequent isolation of Propionibacterium acnes from the shoulder dermis despite skin preparation and prophylactic antibiotics. J Shoulder Elbow Surg. 2016 Feb;25(2):304-10. doi: 10.1016/j.jse.2015.08.002. Epub 2015 Oct 9.
McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev. 1999 Jan;12(1):147-79. doi: 10.1128/CMR.12.1.147.
Edmiston CE Jr, Bruden B, Rucinski MC, Henen C, Graham MB, Lewis BL. Reducing the risk of surgical site infections: does chlorhexidine gluconate provide a risk reduction benefit? Am J Infect Control. 2013 May;41(5 Suppl):S49-55. doi: 10.1016/j.ajic.2012.10.030.
Falconer TM, Baba M, Kruse LM, Dorrestijn O, Donaldson MJ, Smith MM, Figtree MC, Hudson BJ, Cass B, Young AA. Contamination of the Surgical Field with Propionibacterium acnes in Primary Shoulder Arthroplasty. J Bone Joint Surg Am. 2016 Oct 19;98(20):1722-1728. doi: 10.2106/JBJS.15.01133.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C Acnes in TSA
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.