RecruitingNot ApplicableNCT07356323

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


Sponsor

Solventum US LLC

Enrollment

179 participants

Start Date

Feb 19, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (2% w/w CHG) for people with arthroplasty replacement, knee and arthroplasty total hip replacement. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICE3M™ 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

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NCT07356323


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