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A Prospective, Single-arm, Trial to Determine Contamination Rates When Using an Antibacterial Incise Drape During Orthopedic Surgery
Sponsor: Solventum US LLC
Summary
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.
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
179
Start Date
2026-02-19
Completion Date
2026-05
Last Updated
2026-03-09
Healthy Volunteers
No
Interventions
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (2% w/w CHG)
A CHG-impregnated antimicrobial incise drape applied to the surgical site prior to incision during primary hip or knee arthroplasty.
Locations (2)
Indiana University Health (IU Health)
Fishers, Indiana, United States
University of Utah Health - Department of Orthopedics
Salt Lake City, Utah, United States