Chlorhexidine antimicrobial incise drape for hip and knee replacement surgery
A Prospective, Single-arm, Trial to Determine Contamination Rates When Using an Antibacterial Incise Drape During Orthopedic Surgery
This will test a chlorhexidine antimicrobial incise drape to see if it reduces contamination during primary hip or knee replacement surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 179 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Solventum US LLC Industry-sponsored |
| Locations | 2 sites (Fishers, Indiana and 1 other locations) |
| Trial ID | NCT07356323 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 22 years or older who are scheduled for a unilateral primary hip or knee arthroplasty, can provide informed consent, and can return for follow-up visits are ideal candidates.
Not a fit: Patients scheduled for bilateral or revision arthroplasty, those with prior open surgery on the target joint, or those who are pregnant or lactating are excluded and would not be expected to benefit from this study.
Why it matters
Potential benefit: If successful, the drape could lower intraoperative contamination and potentially reduce the risk of postoperative wound infection in hip and knee replacements.
How similar studies have performed: Similar CHG-impregnated incise drapes have been used previously with mixed but generally positive findings for reducing intraoperative contamination, though definitive evidence for reducing surgical site infections is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Fishers, Indiana and 1 other locations
- Indiana University Health (IU Health) — Fishers, Indiana, United States (Not_yet_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.