Recruiting

Wound Irrigation

Sponsor:

Orthopaedic Education and Research Institute (dba Hoag Orthopedics)

Code:

NCT06379919

Conditions

Cutibacterium Acnes Contamination

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Irrisept Irrigation

Saline Irrigation Solution Delivery

Study Details

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.

Conditions

Cutibacterium Acnes Contamination

Study ID

NCT06379919

Start date

Mar 20, 2024

Status verified date

Apr, 2024

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

126 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Normal Saline Irrigation Arm (Group 1)

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.

active comparator: Irrisept irrigation Arm (Group 2)

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.

Interventions

Irrisept 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.

Saline Irrigation Solution Delivery

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

Primary outcome measure

  • C Acnes Presence [ Time Frame: Cultures take during surgery and analyzed over 21 days post surgery ]

Central Contacts and Locations

Central contacts

Vance Gardner, MD

(949) 526-1570anabaino77@gmail.com

Locations

Hoag Orthopedics

Recruiting

Orange, California, United States, 92868

Contacts

Edward Quilligan, BS

949-526-1570Edward.quilligan@hoagorthopedics.org

Kalyn Smith, BS

(949) 526-1570kalyn.smith@hoagorthopedics.org

More Information

Sponsor

Orthopaedic Education and Research Institute (dba Hoag Orthopedics)

Last update posted

Apr 26, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Orthopaedic Education and Research Institute (dba Hoag Orthopedics) on 2024-04-26.