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

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.

Inclusion criteria

• 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.

Exclusion criteria

• Subject is pregnant or lactating prior to surgery.*

*Women who have had surgical sterilization by a medically accepted method (e.g., tubal ligation, hysterectomy, or oophorectomy) or are post-menopausal, defined as not having menstruation for > 12 months will not be required to undergo pregnancy testing

• 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.
• Subject is scheduled for lower extremity arthroplasty due to trauma.
• Subject was previously diagnosed with septic arthritis or has a history of infection in the joint.
• Subject has taken any antibiotics within 4 weeks before surgery.
• Subject has an allergy or sensitivity to components of the device (e.g., chlorhexidine gluconate or acrylate-based adhesive).
• Subject is currently enrolled in another trial.