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Use of 48 Hour Course of Antibiotics to Prevent Surgical Site Infection in Obese Patients Undergoing Cesarean Delivery

NCT01194115 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 475

Last updated 2011-11-11

No results posted yet for this study

Summary

The purpose of this study is to evaluate if preoperative antibiotics, followed by 48 hour course of broad spectrum antibiotics prevents wound infection complications in patients that are obese who undergo cesarean section. Standard antibiotic prophylaxis in all weight women undergoing cesarean section is cefazolin prior to skin incision. It is the hypothesis that a prolonged, 48 hour course of broad spectrum antibiotics that are suited to prevent growth of normal vaginal flora will decrease the rate of surgical site infection in obese patients that are at a greatly increased risk of postoperative infections complications.

Conditions

  • Surgical Site Infection in Obese Women Undergoing C-section

Interventions

DRUG

cephalexin & metronidazole

cephalexin at 500 mg per oral every 8 hours for a total of 6 doses

DRUG

placebo

placebo representing standard of care

Sponsors & Collaborators

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Carri Warshak, MD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01194115 on ClinicalTrials.gov