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RECRUITING
NCT07356323
NA

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

Sponsor: Solventum US LLC

View on ClinicalTrials.gov

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

DEVICE

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