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Antibiotic

Antibiotic Regimen for Surgical Site Infection

N/A

Waitlist Available

Led By Christine Rohde, MD, MPH

Research Sponsored by The Plastic Surgery Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to two years

Awards & highlights

Study Summary

This trial will compare the effectiveness of two antibiotic treatments in preventing surgical site infections (SSIs) in patients undergoing immediate breast reconstruction with tissue expanders. Patients will be randomly assigned to receive either a single dose of antibiotics before surgery, with additional doses as necessary during surgery, or the same treatment plus a week of antibiotics after surgery. The study will assess the rates of SSI from the two groups, as well as the type, duration, and method of subsequent antibiotic use for patients who develop SSIs.

Eligible Conditions

Antibiotic Use
Surgical Site Infection
Breast Reconstruction

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to two years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants in each group who develop surgical site infection (SSI) within 30 days of index procedure.

Secondary outcome measures

Comparison of any secondary infections, including resistant bacterial strains and yeast infections, in participants from the two groups who develop SSI.

ER visit and hospital readmission rates among participants in both groups.

Number of participants in each group who develop an SSI or other complications after 30 days of index procedure.

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: WPO (Arm B)Experimental Treatment2 Interventions

The patients assigned to this arm will receive same pre-op and intraoperative antibiotics similar to SPD (Arm A). In addition, patients in this group will receive one week of post-operative antibiotics (WPO). The post-operative antibiotic will be a first generation Cephalosporin of their surgeon's choice.

Group II: SPD (Arm A)Active Control1 Intervention

Single pre-operative dose of intravenous antibiotics with intraoperative redosing (SPD): Intravenous cefazolin, a cephalosporin antibiotic, will be prescribed to all patients before surgery. All patients will receive one dose of antibiotic within 60 minutes prior to incision, and any intraoperative doses of antibiotics according to current recommendations based on the antibiotic's dosing and on operative time.

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Who is running the clinical trial?

The Plastic Surgery FoundationLead Sponsor

8 Previous Clinical Trials

912 Total Patients Enrolled

Christine Rohde, MD, MPHPrincipal InvestigatorColumbia University

Brian Gastman, MDPrincipal InvestigatorThe Cleveland Clinic

3 Previous Clinical Trials

117 Total Patients Enrolled

Media Library

Intravenous Antibiotics (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04631185 — N/A

Antibiotic Use Research Study Groups: SPD (Arm A), WPO (Arm B)

Antibiotic Use Clinical Trial 2023: Intravenous Antibiotics Highlights & Side Effects. Trial Name: NCT04631185 — N/A

Intravenous Antibiotics (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04631185 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment process for this trial currently underway?

"Affirmative. The information hosted on clinicaltrials.gov verifies that this medical experiment is currently recruiting participants, having been first posted on May 7th 2021 and last amended on September 30th 2022. This research seeks to enrol 1000 patients from 5 separate sites."

Answered by AI

What is the limit of participants for this investigation?

"Correct. According to clinicaltrials.gov, this trial is presently enrolling participants. First posted on May 7th 2021 and most recently revised on September 30th 2022, the study seeks 1000 subjects from 5 distinct sites."

Answered by AI

At what institutions is this experimental protocol being executed?

"Duke University Medical Centre in Durham, NC; Johns Hopkins Universiy in Baltimore, MD; and The University of Chicago in IL are three sites acceptting patients for this trial. Additionally, there are 5 other places where enrollment is possible."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Surgical Site Infection and Antibiotic Use Study

2021. "Surgical Site Infection and Antibiotic Use Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04631185.