NCT07356323

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
179

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

February 19, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2026

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

January 20, 2026

Last Update Submit

March 5, 2026

Conditions

Arthroplasty Replacement, KneeArthroplasty Total Hip Replacement

Keywords

Chlorohexidine GluconateIncise drapeCHGIoban

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Percentage of Subjects With Loss of Incise Drape Adherence Greater Than 10 mm During Surgery

    During surgery

  • Operative Time

    During surgery

Study Arms (1)

Single Treatment Arm

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.

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

Interventions

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

A CHG-impregnated antimicrobial incise drape applied to the surgical site prior to incision during primary hip or knee arthroplasty.

Single Treatment Arm

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Indiana University Health (IU Health)

Fishers, Indiana, 46037, United States

NOT YET RECRUITING

University of Utah Health - Department of Orthopedics

Salt Lake City, Utah, 84108, United States

RECRUITING

Central Study Contacts

Tracy E Swanson

CONTACT

6125417752tswanson@solventum.com

Stephanie Karwedsky

CONTACT

6124272830skarwedsky@solventum.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2026

First Posted

January 21, 2026

Study Start

February 19, 2026

Primary Completion

April 20, 2026

Study Completion

May 1, 2026

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)