RCT on NPWT for Incisions Following Major Lower-limb Amputation to Reduce Surgical Site Infection (NCT03144726) | Clinical Trial Compass
UnknownNot Applicable
RCT on NPWT for Incisions Following Major Lower-limb Amputation to Reduce Surgical Site Infection
290 participantsStarted 2018-03
Plain-language summary
Surgical site infections following lower extremity amputations have been reported in up to 40% of patients. Surgical site infections have significant morbidity and even mortality in terms of emergency room visits, length of hospital stay, reamputation rates and death. Since its introduction, negative pressure wound therapy has been demonstrated to promote wound healing and possibly decreasing the need for future amputations. The aim of the study is to provide level I evidence for the use of negative pressure wound therapy devices in patients undergoing lower extremity amputation.
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:
* any patient 18 years or older undergoing amputation of the lower limb, either an above knee amputation (AKA) or below knee amputation (BKA)
* ability to read and write English to undergo informed consent
Exclusion Criteria:
* patients in which a complete seal cannot be obtained at the time of vacuum placement
* wounds that are not closed primarily
* existing infection
* patient is anticipated to not follow-up
* inability to read and write English
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.
1This trial is testing negative pressure wound therapy on incisions after major lower-limb amputation — is that something my surgical team would consider using on my wound, and how does it differ from standard dressing care I might otherwise receive?
2Since the trial's recruitment status is listed as unknown, can you find out whether this study is still actively enrolling patients, and if not, are there similar trials or protocols using NPWT that I could access?
3The main thing this trial is measuring is surgical site infection after amputation — how big a concern is wound infection in my specific situation, and what does my care team already do to prevent it?
4Because this trial is listed as 'Phase NA,' meaning it may be studying a device or procedure rather than a drug, what is already known about the safety and effectiveness of negative pressure wound therapy on amputation wounds, and would my doctor recommend it outside of a trial?
5What would participation in this trial actually look like day-to-day — for example, how long would I need the wound therapy device, how often would my wound be checked, and would it affect my rehabilitation or prosthetic fitting timeline?
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.