๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2024-04-24

Wound Irrigation Comparative Effectiveness Study (NCT06379919)

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

๐ŸŸข Recruiting Observational / Diagnostic ๐Ÿฉบ Clinical Procedure Protocol Sponsor: Orthopaedic Education and Research Institute (dba Hoag Orthopedics)

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Hoag Orthopedics โ€” Orange, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

  • Irrisept Irrigation (PROCEDURE)
  • Saline Irrigation Solution Delivery (PROCEDURE)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Hoag Orthopedics โ€” Orange, California

๐Ÿ“ž Contact the Study Coordinator

Phone: (949) 526-1570

Email: anabaino77@gmail.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—