πŸ›οΈ Verified NIH Record β€’ Updated 2026-06-29

A Prospective, Single-arm, Trial to Determine Contamination Rates When Using an Antibacterial Incise Drape During Orthopedic Surgery (NCT07356323)

🟒 Recruiting Observational / Diagnostic βš™οΈ Medical Device Protocol Sponsor: Solventum US LLC

🩺 Plain-English Summary (8th-Grade Level)

The goal of this clinical study is to generate data on the intended use of a chlorhexidine gluconate (CHG)-impregnated antimicrobial incise drape. The study includes subjects undergoing primary hip or knee arthroplasty procedures. The study evaluates the intraoperative performance and safety of the incise drape during surgery, including assessment of contamination and operative characteristics. Participants will have a CHG-impregnated antimicrobial incise drape applied during their surgical procedure. During surgery, samples will be collected from the operative site to assess potential bacterial contamination.

Who can join: Review the eligibility criteria below.

Location: Indiana University Health (IU Health) β€” Fishers, Indiana

Age range: 22 Years

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

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

πŸ“ All Participating Trial Locations (2 Sites)

  • Indiana University Health (IU Health) β€” Fishers, Indiana
  • University of Utah Health - Department of Orthopedics β€” Salt Lake City, Utah

πŸ“ž Contact the Study Coordinator

Phone: (612) 541-7752

Email: tswanson@solventum.com

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

πŸ’° 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 Β§ 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.

πŸ’‘ 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.
πŸ›οΈ View Official NIH Record β†—