Actively Recruiting
A Prospective, Single-arm, Trial to Determine Contamination Rates When Using an Antibacterial Incise Drape During Orthopedic Surgery
Led by Solventum US LLC · Updated on 2026-03-09
179
Participants Needed
2
Research Sites
10 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
A Prospective, Single-arm, Trial to Determine Contamination Rates When Using an Antibacterial Incise Drape During Orthopedic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is 63 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 will not qualify if you...
- Subject is pregnant or lactating prior to surgery. Women who have had surgical sterilization or are post-menopausal are exempt from 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 for revision knee arthroplasty.
- Subject had 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 diagnosed with septic arthritis or has a history of joint infection.
- Subject has taken antibiotics within 4 weeks before surgery.
- Subject has allergy or sensitivity to device components, such as chlorhexidine gluconate or acrylate-based adhesive.
- Subject is currently enrolled in another trial.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Indiana University Health (IU Health)
Fishers, Indiana, United States, 46037
Not Yet Recruiting
2
University of Utah Health - Department of Orthopedics
Salt Lake City, Utah, United States, 84108
Actively Recruiting
Research Team
T
Tracy E Swanson
CONTACT
S
Stephanie Karwedsky
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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