Recruiting

CHG-Impregnated Drape

Sponsor:

Solventum US LLC

Code:

NCT07356323

Conditions

Arthroplasty Replacement, Knee

Arthroplasty Total Hip Replacement

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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.

Conditions

Arthroplasty Replacement, Knee

Arthroplasty Total Hip Replacement

Study ID

NCT07356323

Start date

Feb 19, 2026

Status verified date

Jun, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Sep 4, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

179 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Single Treatment Arm

Subjects undergoing primary hip or knee arthroplasty will have a chlorhexidine gluconate (CHG)-impregnated antimicrobial incise drape applied to the surgical site prior to incision and maintained in place for the duration of the surgical procedure.

Interventions

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.

Primary outcome measure

  • Evaluation of the presence of contamination at the surgical site during the operative procedure. [ Time Frame: During surgery ]

Central Contacts and Locations

Central contacts

Tracy E Swanson

6125417752tswanson@solventum.com

Stephanie Karwedsky

6124272830skarwedsky@solventum.com

Locations

Indiana University Health (IU Health)

Recruiting

Fishers, Indiana, United States, 46037

Principal Investigator:

Leonard T Buller, MD

University of Utah Health - Department of Orthopedics

Recruiting

Salt Lake City, Utah, United States, 84108

Principal Investigator:

Jeremy Gililland, MD

More Information

Sponsor

Solventum US LLC

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • Chlorohexidine Gluconate
  • Incise drape
  • CHG
  • Ioban

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Solventum US LLC on 2026-07-01.