Recruiting soon

Chlorhexidine Gluconate Antimicrobial Incise Drape for Infection Prevention in Orthopedic Surgery

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Study Aim

This study aims to evaluate the effectiveness of Chlorhexidine Gluconate Antimicrobial Incise Drape in preventing contamination at the surgical site during orthopedic surgery.

What is being tested

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

Device
Who is being recruted

Over 22 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: February 2026
See protocol details

Summary

Principal SponsorSolventum US LLC
Study ContactTracy E SwansonMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2026

Actual date on which the first participant was enrolled.

This clinical trial aims to understand how well an antibacterial incise drape, infused with chlorhexidine gluconate (CHG), works in preventing contamination during lower extremity orthopedic surgeries, specifically primary hip or knee replacements. The study is important because it can help improve surgical safety and reduce the risk of infections, a common challenge in such procedures. During the surgery, the CHG-impregnated drape is used at the surgical site. The study measures its performance and safety throughout the operation. The main outcome being evaluated is the presence of contamination at the surgical site. This helps determine if the drape is effective in maintaining a clean and safe surgical environment.

Official TitleA Prospective, Single-arm, Trial to Determine Contamination Rates When Using an Antibacterial Incise Drape During Orthopedic Surgery
NCT07356323
Principal SponsorSolventum US LLC
Study ContactTracy E SwansonMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

179 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 22 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
Subject is willing and able to return for all visits.
Subject is scheduled to undergo a unilateral primary arthroplasty procedure on a hip or knee.
Subject is capable of providing informed consent.
Subject is ≥ 22 years of age on the day of surgery.
9 exclusion criteria prevent from participating
Subject has had a previous open knee surgery on the study knee or is scheduled to undergo a revision knee arthroplasty.
Subject has taken any antibiotics within 4 weeks before surgery.
Subject is currently enrolled in another trial.
Subject is scheduled to undergo a lower extremity bilateral arthroplasty procedure.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Indiana University Health (IU Health)

Fishers, United StatesOpen Indiana University Health (IU Health) in Google Maps
Suspended

University of Utah Health - Department of Orthopedics

Salt Lake City, United States
Recruiting soon2 Study Centers