Chlorhexidine antimicrobial incise drape for hip and knee replacement surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-arm study enrolls adults having unilateral primary hip or knee arthroplasty at participating U.S. centers. A chlorhexidine (CHG)-impregnated antimicrobial incise drape will be applied during the operation. Intraoperative samples will be collected from the surgical site to measure bacterial contamination and to record operative characteristics. Safety and intraoperative performance of the drape will be monitored throughout the perioperative period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Indiana University Health (IU Health)
  Fishers, Indiana, United States Recruiting
• University of Utah Health - Department of Orthopedics
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Study coordinator: Tracy E Swanson
• Email: tswanson@solventum.com
• Phone: 6125417752

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.