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NCT Number: NCT06379919

Wound Irrigation Comparative Effectiveness Study

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.

Recruiting

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Key information

Conditions

Cutibacterium Acnes Contamination

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Chlorohexidine Gluconate Solution Delivery

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.

Primary outcomes

  1. C Acnes Presence

    Time frame: Cultures take during surgery and analyzed over 21 days post surgery

    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

Secondary outcomes

  1. American Shoulder and Elbow Surgeons Patient Reported Outcome Measure

    Time frame: Pre-operation, 3, 6, 12, & 24 Months post-operation,

    This assessment consists of 17, multiple choice questions that pertain to pain and function of the operated shoulder.

  2. Shoulder Range of Motion (ROM)

    Time frame: Pre-operation, 3, 6, 12, & 24 Months post-operation,

    Shoulder Range of Motion will require the Investigator or Designee to evaluate the following degrees of freedom:

    Forward flexion

    External Rotation with elbow at side

    External Rotation with elbow at 900

    Internal Rotation as measured by spinal segment reached.

Study contacts

Contact information is provided by the study sponsor or research team.

Vance Gardner, MD

CONTACT

[email protected]

(949) 526-1570

Sponsors and collaborators

Lead sponsor

Orthopaedic Education and Research Institute (dba Hoag Orthopedics)

Other

Collaborators

  • Irrimax Corporation

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Apr 23, 2024
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.