RecruitingNot ApplicableNCT06379919

Wound Irrigation Comparative Effectiveness Study

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


Sponsor

Orthopaedic Education and Research Institute (dba Hoag Orthopedics)

Enrollment

126 participants

Start Date

Mar 20, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Irrisept Irrigation and a procedure called Saline Irrigation Solution Delivery for people with cutibacterium acnes contamination. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREIrrisept 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.

PROCEDURESaline Irrigation Solution Delivery

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


Locations(1)

Hoag Orthopedics

Orange, California, United States

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NCT06379919