Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections

September 16, 2023 updated by: Sara Abdallah Mohamed Salem, Beni-Suef University

The Impact of Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections

the aim of this study is to evaluate the efficacy of employing cefepime (CFM) versus ampicillin/sulbactam (AMS) in lowering the rate of post-cesarean surgical site infections.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

A prospective randomized clinical study conducted in the department of obstetrics and gynecology of Beni-Suef University Hospital . A total of 213 women were assessed for eligibility, 13 of which were excluded. A total of 200 pregnant women who were eligible for elective cesarean sections (CS). The overall median duration of postoperative followed up was from 10 days to one month to determine the surgical site infection (SSI).

Study Type

Interventional

Enrollment (Actual)

213

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Beni Suef
      • Banī Suwayf, Beni Suef, Egypt, 62521
        • Beni-suef university Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pregnant women within age group more than18 years.
  • Pregnant women with elective cesarean delivery.
  • Previous and primary cesarean delivery.

Exclusion Criteria:

Severe hepatic disease women Emergent cesarean deliveries. Women with medical disorders as pre-gestational diabetes, anemia, hypertension, or preeclampsia.

Women who had a skin infection adjacent to the operative site.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cefepime Group
Pregnant women (n=100) received IV cefepime (CEF) (maxipime®1000mg) 30 minutes before cesarean delivery (CD) and 12 hours after CD
Drug: Cefepime 1000 MG
Cefepime is a fourth-generation cephalosporin antibiotic
Other Names:
  • maxipime
Active Comparator: Ampicillin/Sulbactam
Pregnant women (n=100) received IV Ampicillin/Sulbactam (AMS) (Unictam® 1500 mg) 30 minutes before CD and 12 hours after CD
Drug: Ampicillin-sulbactam
Broad-Spectrum Antibiotic
Other Names:
  • unictam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgical site infection
Time Frame: 1 month
pain, redness, swelling, warm skin around the wound, yellow or green discharge
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Investigators

  • Principal Investigator: Beni-Suef University, Faculty of Medicine Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

September 15, 2023

Study Completion (Estimated)

September 20, 2023

Study Registration Dates

First Submitted

September 16, 2023

First Submitted That Met QC Criteria

September 16, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 16, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • maxipime in cs

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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