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Recruiting Not applicable

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

NCT07356323 · tracked via the Priya Life Science USA tracker
Sponsor
Solventum US LLC
Phase
Not applicable
Started
2026-02-19
Last updated
2026-07-01

Condition(s) studied

Arthroplasty Replacement, KneeArthroplasty Total Hip Replacement

Investigational drug(s) / intervention(s)

3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (2% w/w CHG)

3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (2% w/w CHG): A CHG-impregnated antimicrobial incise drape applied to the surgical site prior to incision during primary hip or knee arthroplasty.

Study summary

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.

Eligibility

Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Evaluation of the presence of contamination at the surgical site during the operative procedure. — During surgery
    Assessment of contamination at the surgical site during the operative procedure.

Trial sites (2)

FacilityCityRegionStatus
Indiana University Health (IU Health) Fishers Indiana Recruiting
University of Utah Health - Department of Orthopedics Salt Lake City Utah Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07356323 on ClinicalTrials.gov ↗ ← All trials in the USA