WithdrawnNot Applicable

The Role of Guideline-adherent Perioperative Antibiotic Administration and the Risk of Surgical Site Infections After Non-cardiac Surgery.

Stopped: no funding

United States0Started 2019-06-01

Plain-language summary

This study will seek to describe current practice of antibiotic prophylaxis to identify the effect of appropriate perioperative antimicrobial coverage - specifically regarding timing, dose adjustments, and redosing - on surgical site infections (SSI).

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.

Exclusion criteria

. Emergency surgery
. Open wound with or without infection
. Current active infection
. Transfusion of 4 or more units of packed red blood cells during surgery
. Preoperative sepsis or systemic inflammatory response syndrome within 48 hours prior to surgery 6 Ventilator dependence within 48 hours of surgery 7 Surgery within preceding 30 days 8 Ongoing preoperative antibiotic therapy 9 Missing perioperative antibiotic/medication documentation 10 Ophthalmic surgeries 11 Organ Transplants 12 Organ harvesting surgeries 13 ASA 5,6 14 Cardiac Surgeries 15 Age \<18 years
. Emergency surgery
. Ongoing preoperative antibiotic therapy 3. Missing perioperative antibiotic/medication documentation

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

Lower incidence of SSI due to timing

Timeframe: 7 years

Lower incidence of SSI due to dose adjustments

Timeframe: 7 years

Lower incidence of SSI due to redosing

Timeframe: 7 years

Trial details

NCT IDNCT03982810

SponsorYale University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-03

View on ClinicalTrials.gov More Surgical Site Infection trials

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.

Exclusion criteria

. Emergency surgery
. Open wound with or without infection
. Current active infection
. Transfusion of 4 or more units of packed red blood cells during surgery
. Preoperative sepsis or systemic inflammatory response syndrome within 48 hours prior to surgery 6 Ventilator dependence within 48 hours of surgery 7 Surgery within preceding 30 days 8 Ongoing preoperative antibiotic therapy 9 Missing perioperative antibiotic/medication documentation 10 Ophthalmic surgeries 11 Organ Transplants 12 Organ harvesting surgeries 13 ASA 5,6 14 Cardiac Surgeries 15 Age \<18 years
. Emergency surgery
. Ongoing preoperative antibiotic therapy 3. Missing perioperative antibiotic/medication documentation