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

NCT07356323 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2026-07-01

No results posted yet for this 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.

Conditions

  • Arthroplasty Replacement, Knee
  • Arthroplasty Total Hip Replacement

Interventions

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.

Sponsors & Collaborators

  • Solventum US LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-19
Primary Completion
2026-09-04
Completion
2026-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07356323 on ClinicalTrials.gov