Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure or Coverage (NCT01496014) | Clinical Trial Compass
CompletedNot Applicable
Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure or Coverage
United States646 participantsStarted 2011-09
Plain-language summary
The purpose of this study is to characterize the bacteria in the wound "bioburden" at the time of definitive wound coverage/closure of severe tibia fractures in both the military and civilian populations.
Who can participate
Age range
18 Years – 64 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
. All open Grade III tibia fractures (plateau, shaft, pilon) requiring a second procedure following fixation, or traumatic transtibial amputations requiring delayed primary closure, skin grafting and/ or flap coverage.
. Ages 18 - 64 years inclusive
. Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
. Patients may have a traumatic brain injury.
. Patients may have other fractures including spine, upper extremity fractures, contralateral lower extremity injuries, ipsilateral pelvis, hip, femur or foot injuries.
. Patients may be treated initially at an outside institution prior to transfer to the study institution, as long as the definitive fixation was not performed prior to entrance into the study.
. Patients with bilateral injuries that meet inclusion criteria may be included, but only the limb rated as "more severe" by the treating surgeon will be enrolled in the study.
. Patients may have co-existing non-tibial infection, with or without antibiotic treatment.
Exclusion criteria
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.