Wound Irrigation Comparative Effectiveness Study

Orthopaedic Education and Research Institute (dba Hoag Orthopedics)

Status: Enrolling

Conditions: Cutibacterium Acnes Contamination

Treatments: Procedure: Saline Irrigation Solution Delivery; Procedure: Irrisept Irrigation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06379919

C Acnes in TSA

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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126 participants in 2 patient groups

Normal Saline Irrigation Arm (Group 1)

Active Comparator group

Description:

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.

Treatment:

Procedure: Saline Irrigation Solution Delivery

Irrisept irrigation Arm (Group 2)

Active Comparator group

Description:

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.

Treatment:

Procedure: Irrisept Irrigation