NCT07356323

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 179 (estimated)
• Sponsor: Solventum US LLC · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthroplasty Replacement, Knee
• Arthroplasty Total Hip Replacement

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-19
• Primary completion: 2026-04-20
• Completion: 2026-05-01
• First posted: 2026-01-21
• Last updated: 2026-03-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study