Wound Irrigation Comparative Effectiveness Study

NCT06379919 | Recruiting

• 1 other identifier: C Acnes in TSA
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to compare the presence of C acnes in bacteriologic cultures taken from participant samples of subcutaneous and deep tissue prior to deep surgical irrigation using either Normal Saline Irrigation (Group 1) or Irrisept Irrigation (Group 2). Secondary objectives are evaluation of patient reported outcome measures and range of motion in relation to C acnes presence among subjects in the two groups.

Conditions

Cutibacterium Acnes Contamination

Outcome Measures

Primary Outcomes (1)

• C Acnes Presence

  The primary outcome of this study is to compare the presence of C acnes in bacteriologic cultures taken from participant samples of subcutaneous and deep tissue prior to deep surgical irrigation using either Normal Saline Irrigation (Group 1) or Irrisept Irrigation (Group 2)rimary objecti

  Cultures take during surgery and analyzed over 21 days post surgery

Secondary Outcomes (2)

• American Shoulder and Elbow Surgeons Patient Reported Outcome Measure

  Pre-operation, 3, 6, 12, & 24 Months post-operation,

• Shoulder Range of Motion (ROM)

  Pre-operation, 3, 6, 12, & 24 Months post-operation,

Study Arms (2)

Normal Saline Irrigation Arm (Group 1)

ACTIVE COMPARATOR

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.

Procedure: Saline Irrigation Solution Delivery

Irrisept irrigation Arm (Group 2)

ACTIVE COMPARATOR

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.

Procedure: Irrisept Irrigation

Interventions

Irrisept Irrigation PROCEDURE

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.

Also known as: Chlorohexidine Gluconate Solution Delivery

Irrisept irrigation Arm (Group 2)

Saline Irrigation Solution Delivery PROCEDURE

Normal saline is isotonic and the most commonly used wound irrigation solution due to safety (lowest toxicity) and physiologic factors.

Normal Saline Irrigation Arm (Group 1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ault patients requiring Total Shoulder Arthroplasty

You may not qualify if:

• Age younger than 18 years
• 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

Sponsors & Collaborators

• Orthopaedic Education and Research Institute (dba Hoag Orthopedics): lead
• Irrimax Corporation: collaborator

Study Sites (1)

Hoag Orthopedics

Orange, California, 92868, United States

RECRUITING

Related Publications (17)

• 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.

  PMID: 17321157 BACKGROUND

• 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.

  PMID: 25979553 BACKGROUND

• 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.

  PMID: 33373684 BACKGROUND

• 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.

  PMID: 25823673 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

• 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.

  PMID: 21240577 BACKGROUND

• 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.

  PMID: 32827305 BACKGROUND

• 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.

  PMID: 31291202 BACKGROUND

• 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.

  PMID: 33895302 BACKGROUND

• 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.

  PMID: 25199422 BACKGROUND

• 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.

  PMID: 31471244 BACKGROUND

• 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.

  PMID: 26456428 BACKGROUND

• 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.

  PMID: 9880479 BACKGROUND

• 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.

  PMID: 23622749 BACKGROUND

• 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.

  PMID: 27869623 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

• 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

Study Officials

• Hafiz F Kassam, MD

  Hoag Orthopedics Education and Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vance Gardner, MD

CONTACT

(949) 526-1570; anabaino77@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and Microbiology lab assessing cultures are blinded to the assigned irrigation treatment arm throughout the length of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned at the beginning of the study to treatment arm involving 1 of 2 types of irrigation treatment for their surgery. They continue in that arm through the length of the study and complete the same study procedures, as well as same standard of care.

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: March 20, 2024
• Primary Completion: May 31, 2025
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)