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

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.

Study Overview

• Status: Recruiting
• Conditions: Arthroplasty Replacement, Knee; Arthroplasty Total Hip Replacement
• Intervention / Treatment: Device: 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (2% w/w CHG)

Detailed Description

This is a prospective, single-arm clinical study conducted in the United States in subjects undergoing primary hip or knee arthroplasty. The study evaluates the intraoperative performance and safety of a chlorhexidine gluconate (CHG)-impregnated antimicrobial incise drape used during lower extremity orthopedic surgery.

Safety and intraoperative performance outcomes will be assessed throughout the study.

• Study Type: Interventional
• Enrollment (Estimated): 179
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tracy E Swanson; Phone Number: 6125417752; Email: tswanson@solventum.com
• Study Contact Backup: Name: Stephanie Karwedsky; Phone Number: 6124272830; Email: skarwedsky@solventum.com

Study Locations

• United States
  • Indiana
    • Fishers, Indiana, United States, 46037
      • Not yet recruiting
      • Indiana University Health (IU Health)
      • Principal Investigator: Leonard T Buller, MD
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • Recruiting
      • University of Utah Health - Department of Orthopedics
      • Principal Investigator: Jeremy Gililland, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the presence of contamination at the surgical site during the operative procedure.	Assessment of contamination at the surgical site during the operative procedure.	During surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Loss of Incise Drape Adherence Greater Than 10 mm During Surgery	The percentage of subjects who experience loss of adherence of the incise drape of more than 10 millimeters (mm) at the incision site during the surgical procedure.	During surgery
Operative Time	Operative time measured in minutes	During surgery

Collaborators and Investigators

• Sponsor: Solventum US LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2026
• Primary Completion (Estimated): April 20, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: CHG; Ioban; Chlorohexidine Gluconate; Incise drape
• Other Study ID Numbers: EM-05-015132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes