Efficacy of Surgical Preparation Solutions in Knee Surgery (NCT01857349) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of Surgical Preparation Solutions in Knee Surgery
United States77 participantsStarted 2013-04
Plain-language summary
The goal of this study is to determine the superiority of surgical scrub preparations in total knee arthroplasty based on the bacterial counts present on the skin surface and in the deep joint tissues. These counts will be obtained by culturing the skin prior to any scrub preparation, post preparation after the application of the sterile drapes, deep joint tissue sample prior to wound closure, and immediately post wound closure. This study will provide an assessment of the management of sterility by comparing quantitative and qualitative cultures immediately after surgical scrub preparation and the maintenance of sterility throughout the procedure. This study will enhance prior research efforts by contributing quantitative bacterial load and bacterial load within the surgical wound at closure.
Who can participate
Age range
18 Years – 89 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:
* \>18 years old and less than 89
* Undergoing primary total knee arthroplasty
* Not undergoing surgical intervention for infection
Exclusion Criteria:
Injury due to trauma
* Open wound at the incision site determined by pre-op history and physical
* Abrasion in the vicinity of the planned incision site determined by pre-op history and physical
* Active infection at or near the surgical incision site determined by pre-op history and physical
* Active infection somewhere else in the body determined by pre-op labs and history and physical
* Prior history of surgical infection or bacteremia determined by pre-op history and physical
* History of rheumatoid arthritis determined by pre-op history and physical
* History of autoimmune disorder determined by pre-op history and physical
* Immunosuppressed patient determined by pre-op history and physical
* Known allergy to iodine, isopropyl alcohol or Chlorhexidine
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.
What they're measuring
1
Quantitative and qualitative bacterial load
Timeframe: At time of surgery
Trial details
NCT IDNCT01857349
SponsorTexas Tech University Health Sciences Center