Interventional Study Exploring the Occurrence of Surgical Site Infections. (NCT06661473) | Clinical Trial Compass
CompletedNot Applicable
Interventional Study Exploring the Occurrence of Surgical Site Infections.
United States104 participantsStarted 2024-10-03
Plain-language summary
Interventional study exploring surgical site complication occurrences in high-risk revision patients undergoing TKA or THA using NPWT.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Written informed consent
. Patient ≥ 18 years
. Elective unilateral revision THA or TKA.
. High risk patients for surgical wound complications as deemed by investigators
. Primary closure technique by suture or staples
. Linear or curvilinear incisions ≤ 25 cm in length
. The patient able to understand the study and is willing to consent to the clinical investigation
. Patients able to understand how to operate with the negative pressure system at home
Exclusion criteria
. The need for emergency surgery
. Multiple Incision Approach at the time of surgery (alternative approach from primary surgery using 1 incision is permitted)
. Patients requiring bilateral revision total hip or knee arthroplasty surgery
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. History of multiple infections in the offending joint
. Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and superabsorbent powders (polyacrylates) (within the dressing)
. Subjects with contraindications (as per the Avance Solo Instructions for use)
. Pregnant, breastfeeding females, or females of childbearing potential not willing to use contraception for the duration of the investigation