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Surgical Site Infection and Antibiotic Use Study

NCT04631185 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2024-05-29

No results posted yet for this study

Summary

This study is a prospective, multi-institutional, noninferiority, randomized control trial that will compare the efficacy of two antibiotic treatments in preventing SSI in patients receiving immediate breast reconstruction with tissue expanders (TE-BR). The patients will be randomly assigned to one of the two treatment groups. One group will receive a single dose of antibiotics just before surgery and if necessary, more doses during the surgery. The other group will receive the same treatment as the first group, along with an additional week of antibiotics after surgery. The study will assess the rates of SSI from the two groups. It will also assess the type, duration and method (oral vs. intravenous) of subsequent antibiotic use for patients who develop SSIs in each group.

Conditions

  • Surgical Site Infection
  • Breast Reconstruction
  • Antibiotic Use

Interventions

DRUG

Single pre-operative dose of intravenous antibiotics with intraoperative redosing

Intravenous cefazolin, a cephalosporin antibiotic, will be prescribed to all patients before surgery. In case of allergy to cefazolin, intravenous clindamycin will be prescribed. For allergy to both antibiotics, an appropriate antibiotic should be chosen by the surgeon and documented. 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.

DRUG

One week of post-operative antibiotics

The patients will be prescribed one week of Cephalosporin Antibiotic (Keflex/Duricef/Other) of their surgeon's choice.

Sponsors & Collaborators

  • The Plastic Surgery Foundation

    lead OTHER

Principal Investigators

  • Christine Rohde, MD, MPH · Columbia University

  • Brian Gastman, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-07
Primary Completion
2023-12-31
Completion
2024-05-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04631185 on ClinicalTrials.gov