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Recruiting NCT06379919

Wound Irrigation Comparative Effectiveness Study

No phase Interventional Cutibacterium Acnes Contamination

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Irrisept Irrigation, Saline Irrigation Solution Delivery.
Who it may be relevant to
Registry conditions: Cutibacterium Acnes Contamination. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Cutibacterium Acnes Removal by Wound Irrigation With Normal Saline Versus Irrisept During Total Shoulder Arthroplasty

Overview

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.

Interventions

  • Procedure 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.
  • Procedure Saline Irrigation Solution Delivery
    Normal saline is isotonic and the most commonly used wound irrigation solution due to safety (lowest toxicity) and physiologic factors.

Primary outcome measures

  • C Acnes Presence [Time frame: Cultures take during surgery and analyzed over 21 days post surgery]
Secondary outcome measures (2)
  • American Shoulder and Elbow Surgeons Patient Reported Outcome Measure [Time frame: Pre-operation, 3, 6, 12, & 24 Months post-operation,]
  • Shoulder Range of Motion (ROM) [Time frame: Pre-operation, 3, 6, 12, & 24 Months post-operation,]

Eligibility criteria

Inclusion criteria

  • Ault patients requiring Total Shoulder Arthroplasty

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Hoag Orthopedics — Orange

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06379919 · C Acnes in TSA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗