Wound Irrigation Comparative Effectiveness Study

Orthopaedic Education and Research Institute (dba Hoag Orthopedics)126 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

126

Conditions

Cutibacterium Acnes Contamination

Interventions

Irrisept IrrigationPROCEDURE

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.

Saline Irrigation Solution DeliveryPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hoag Orthopedics

Orange, California, United States

RECRUITING

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

American Shoulder and Elbow Surgeons Patient Reported Outcome Measure

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

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

Shoulder Range of Motion (ROM)

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.

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

Central Contacts

Vance Gardner, MD

CONTACT

(949) 526-1570 anabaino77@gmail.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.