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

Recruiting N/A Interventional Study
Arthroplasty Replacement, Knee Arthroplasty Total Hip Replacement
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
22 and older
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
179 (estimated)
Sponsor
Solventum US LLC · Industry
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About This Trial
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. …
Trial Locations
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Eligibility Criteria
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: …
Contacts

Tracy E Swanson

6125417752

tswanson@solventum.com

CONTACT

Stephanie Karwedsky

6124272830

skarwedsky@solventum.com

CONTACT