A Prospective, Single-arm, Trial to Determine Contamination Rates When Using an Antibacterial Incise Drape During Orthopedic Surgery
Start Date
2/19/2026
Completion Date
10/1/2026
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.
Detailed Description
This is a prospective, single-arm clinical study conducted in the United States in subjects undergoing primary hip or knee arthroplasty. The study evaluates the intraoperative performance and safety of a chlorhexidine gluconate (CHG)-impregnated antimicrobial incise drape used during lower extremity orthopedic surgery. Safety and intraoperative performance outcomes will be assessed throughout the study.
Eligibility Criteria
Age Range: 22 years to No maximum
Interventions
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (2% w/w CHG)
Conditions
Locations
Indiana University Health (IU Health)
Fishers, Indiana 46037
United States
University of Utah Health - Department of Orthopedics
Salt Lake City, Utah 84108
United States