A Prospective, Single-arm, Trial to Determine Contamination Rates When Using an Antibacterial Incise Drape During Orthopedic Surgery
Solventum US LLC · NCT07356323
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 22+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 179
- US sites recruiting
- 2
- Study start
- February 19, 2026
- Record last updated
- July 1, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (2% w/w CHG)
Conditions: Arthroplasty Replacement, Knee; Arthroplasty Total Hip Replacement
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Indiana University Health (IU Health)
Fishers, IN 46037
Site contact: Leonard T Buller, MD
University of Utah Health - Department of Orthopedics
Salt Lake City, UT 84108
Site contact: Jeremy Gililland, MD
Study contacts (from the official record)
- Tracy E Swanson · 6125417752 · tswanson@solventum.com
- Stephanie Karwedsky · 6124272830 · skarwedsky@solventum.com