A Prospective, Single-Arm, Trial to Determine Contamination Rates when Using an Antibacterial Incise Drape During Orthopedic Surgery
Antibacterial Drape Study in Surgery
Leonard Buller
Primary Investigator
Brief description of study
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.
Detailed description of study
The primary objective of this study is to determine the efficacy and safety of the Ioban™ CHG Incise Drape in mitigating intraoperative contamination during primary hip or knee arthroplasty surgery. 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.Surgical sites of each Subject will be covered with an Ioban™ CHG Incise Drape for the duration of the surgery. The Ioban™ CHG Incise Drape will be applied according to the manufacturer’s instructions for use (IFU). The incise drape will be used according to the intended use for the product.
The entire duration of the study is expected to last 1 year. Individual subject participation is expected to last up to 43 days, including a screening period lasting up to 42 days, and the day of surgery.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Arthroplasty Total Hip Replacement
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Age: 22 years - 100 years
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Gender: All
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.
This study investigates the use of an antibacterial drape in orthopedic surgeries, specifically hip or knee replacements. The purpose is to see how well the drape works in preventing contamination during surgery. An incise drape is a type of covering used during surgery to keep the area clean and prevent germs from causing infections.
In this study, participants will have a special drape placed on their surgical site during their procedure. The drape will be used exactly as the instructions say. This will help researchers learn about its safety and effectiveness in keeping the surgical area clean.
- Who can participate: Adults aged 22 and older scheduled for a single hip or knee replacement surgery can join. They must give informed consent and attend all study visits.
- Study details: Participants will have an antibacterial drape placed on their surgical site during surgery. They must follow all study instructions.
- Study timelines: The study will last 1 year.
