Study of a Chlorhexidine Gluconate Antimicrobial Incise Drape to Reduce Contamination During Hip or Knee Replacement Surgery

What this Trial Is About

Researchers are studying the use of a chlorhexidine gluconate CHG-impregnated antimicrobial incise drape during primary hip or knee replacement surgeries. This clinical trial aims to evaluate the drapes performance and safety, focusing on contamination rates and operative characteristics during surgery. The study is prospective, single-arm, and conducted in the United States with adult participants aged 22 years and older. Participants will have the CHG-impregnated incise drape applied to the surgical site before the incision and it will remain in place for the entire surgery. The study focuses on patients undergoing unilateral primary hip or knee arthroplasty procedures. The device application and monitoring occur only during the surgical procedure. During surgery, samples will be taken from the operative site to assess possible bacterial contamination. Safety and intraoperative performance outcomes will be measured throughout the procedure. Participants must be able to provide informed consent and return for all visits. The study will be completed by October 2026, with the primary outcome being the presence of contamination at the surgical site during surgery.

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