Wound Irrigation Comparative Effectiveness Study

Not Applicable

Recruiting

• Conditions: Cutibacterium Acnes Contamination
• Interventions: Procedure: Saline Irrigation Solution Delivery; Procedure: Irrisept Irrigation

• Registration Number: NCT06379919
• Lead Sponsor: Orthopaedic Education and Research Institute (dba Hoag Orthopedics)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-20
• Status Verified: 2024-04
• Study First Submitted: 2024-04-18
• Study First Submitted QC: 2024-04-18
• Study First Posted: 2024-04-23
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-26
• Primary Completion: 2025-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline Irrigation Arm (Group 1)	Saline Irrigation Solution Delivery	After deep dissection, and prior to implantation of components, 100 cc of normal saline will be irrigated into the deep wound and progress outward through more superficial planes to the skin. Cultures will then be taken at multiple wound depths and time points.
Irrisept irrigation Arm (Group 2)	Irrisept Irrigation	After deep dissection, and prior to implantation of components, 100 cc of Irrisept solution will be irrigated into the deep wound and progress outward through more superficial planes to the skin. Cultures will then be taken at multiple wound depths and time points.

Primary Outcome Measures

Name	Time	Method
C Acnes Presence	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 Outcome Measures

Name	Time	Method
Shoulder Range of Motion (ROM)	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.
American Shoulder and Elbow Surgeons Patient Reported Outcome Measure	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.

Trial Locations

Locations (1)

Hoag Orthopedics; 🇺🇸 Orange, California, United States