WithdrawnNot Applicable

Negative Pressure Wound Therapy for Surgical Site Infection Prevention in Common Femoral Artery Exposure

Stopped: not recruiting patients.

United States0Started 2018-03-26

Plain-language summary

The purpose of this randomized clinical trial is to investigate the role of negative pressure wound therapy (NPWT) vs standard sterile gauze therapy on the incidence of surgical site infections (SSI) in primarily closed groin incisions in high risk patients undergoing any open common femoral artery exposure for a vascular surgery procedure.

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: One or more of the following * Body Mass Index \>30 kg/m2 * Critical limb ischemia defined by Ankle Brachial Index\<0.35, rest pain, tissue loss and/or non-healing ulcers * Procedure time \>240 min * End Stage Renal Disease on dialysis * Glycated hemoglobin ≥ 8.5% * Transfusion ≥ 3 units packed Red Blood Cells * Previous femoral artery cut-down Exclusion Criteria:Any of the following * Preexisting groin infection * Complete vacuum seal cannot be achieved with negative pressure device * Allergy to Adhesive Material * Groin Surgery within last 30 days

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

Superficial surgical site infection

Timeframe: 30 days postoperatively

Trial details

NCT IDNCT03935659

SponsorHenry Ford Health System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-31

View on ClinicalTrials.gov More Surgical Site Infection trials