Clinical trial NCT06379919: Wound Irrigation Comparative Effectiveness Study
Official title: Cutibacterium Acnes Removal by Wound Irrigation With Normal Saline Versus Irrisept During Total Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cutibacterium Acnes Contamination
Lead sponsor: Orthopaedic Education and Research Institute (dba Hoag Orthopedics)
Sponsor class: OTHER
Collaborators: name: Irrimax Corporation
First posted: 2024-04-23
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: C Acnes Presence
timeFrame: Cultures take during surgery and analyzed over 21 days post surgery
Secondary outcomes:
measure: American Shoulder and Elbow Surgeons Patient Reported Outcome Measure
timeFrame: Pre-operation, 3, 6, 12, & 24 Months post-operation,
measure: Shoulder Range of Motion (ROM)
timeFrame: Pre-operation, 3, 6, 12, & 24 Months post-operation,
Other outcomes:
Locations:
city: Orange
country: United States
facility: Hoag Orthopedics
state: California
Study officials:
affiliation: Hoag Orthopedics Education and Research
name: Hafiz F Kassam, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: 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.
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citation: 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.
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