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

Solventum US LLC

Status: Not yet enrolling

Conditions: Arthroplasty Total Hip Replacement; Arthroplasty Replacement, Knee

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07356323

EM-05-015132

Details and patient eligibility

About

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.

Full 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.

Enrollment: 179 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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179 participants in 1 patient group

Single Treatment Arm

Experimental group

Description:

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.

Treatment:

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