BridgeMD
New treatment option for Arthroplasty Replacement, Knee
Official title A Prospective, Single-arm, Trial to Determine Contamination Rates When Using an Antibacterial Incise Drape During Orthopedic Surgery
ClinicalTrials.gov ID: NCT07356323
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- 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.
You likely can't join if
- Subject is pregnant or lactating prior to surgery.\ \ Women who have had surgical sterilization by a medically accepted method (e.g., tubal ligation...
- 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.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Fishers, Indiana, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fishers, Indiana, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.