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

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.

NCT Number	NCT07356323
Lead Sponsor	Solventum US LLC
Conditions	Arthroplasty Replacement, Knee, Arthroplasty Total Hip Replacement
Enrollment	179 participants
Start Date	2026-02-19
Primary Completion	2026-09-04 (estimated)
Study Completion	2026-10 (estimated)
Updated on ClinicalTrials.gov	2026-07-01