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

Conditions

• Arthroplasty Replacement, Knee
• Arthroplasty Total Hip Replacement

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Feb 19, 2026

Status verified

Mar 2026

Primary completion

Apr 20, 2026

Completion

May 31, 2026

Study Design

Enrollment

179 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

• Tracy E Swanson
  6125417752
  [email protected]
• Stephanie Karwedsky
  6124272830
  [email protected]

Locations (2)

Find similar trials in Fishers, IN