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.
Subject is ≥ 22 years of age on the day of surgery.
Subject is scheduled to undergo a unilateral primary arthroplasty procedure on a hip or knee.
Subject is capable of providing informed consent.
Subject is willing and able to return for all visits.
Subject is pregnant or lactating prior to surgery.*
Subject is scheduled to undergo a lower extremity bilateral arthroplasty procedure.
Subject had a previous open knee surgery on the study knee or is scheduled to undergo a revision knee arthroplasty.
Subject has had a previous surgery for revision femoral acetabular osteotomy or total hip arthroplasty on the study hip.
Single group
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (2% w/w CHG)
DeviceA CHG-impregnated antimicrobial incise drape applied to the surgical site prior to incision during primary hip or knee arthroplasty.
Evaluation of the presence of contamination at the surgical site during the operative procedure.
Assessment of contamination at the surgical site during the operative procedure.
Percentage of Subjects With Loss of Incise Drape Adherence Greater Than 10 mm During Surgery
The percentage of subjects who experience loss of adherence of the incise drape of more than 10 millimeters (mm) at the incision site during the surgical procedure.
Operative Time
Operative time measured in minutes
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