Effect of Cefazolin and Normal Saline Irrigation on Surgical Site Infections (SSIs)

October 12, 2012 updated by: Mohammad E Shahrzad, MD, Hormozgan University of Medical Sciences

Comparison of the Effect of Cefazolin and Normal Saline Irrigation With no Irrigation on the Incidence of Surgical Site Infections

This study conducted to assess the effects of normal saline or cefazolin irrigation on the incidence of SSIs.

Hypothesis:

Normal saline or cefazolin irrigation decreases the incidence of SSIs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All pregnant women who underwent cesarean after 6 hours passed their rupture of membrane and attended to Shariati Hospital of Bandarabbass were eligible for our study.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pregnant women
  • 6 hours passed their rupture of membrane
  • needed to undergo cesarean

Exclusion Criteria:

  • allergy to penicillin
  • allergy to cefazolin
  • history of immunosuppressive drug use
  • gestational diabetes mellitus
  • preeclampsia

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
No Intervention: Control
Experimental: Cefazolin
after the surgery and before closing up the patients, 2 grams of cefazolin in 5 cc of distilled water was used to irrigate the patients
Other: Cefazolin irrigation
after the surgery and before closing up the patients, 2 grams of cefazolin in 5 cc of distilled water was used to irrigate the patients
Other Names:
  • Ancef
  • cephazolin
  • cefazoline
  • Cefacidal
  • Cefamezin
  • Cefrina
  • Elzogram
  • Faxilen
  • Gramaxin
  • Kefazol
  • Kefol
  • Kefzolan
  • Kezolin
  • Novaporin
  • Reflin
  • Zinol
  • Zolicef
Experimental: Normal Saline
after the surgery and before closing up the patients, 150 cc of normal saline was used to irrigate the patients
Other: Normal Saline Irrigation
after the surgery and before closing up the patients, 150 cc of normal saline was used to irrigate the patients and in the last group
Other Names:
  • sodium chloride
  • saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SSI
Time Frame: one week after discharge
one week after discharge

Collaborators and Investigators

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

Sponsor

Hormozgan University of Medical Sciences

Investigators

  • Study Director: Maryam Rahmani, MD, Hormozgan University of Medical Sciences

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

December 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

March 26, 2012

First Submitted That Met QC Criteria

March 28, 2012

First Posted (Estimate)

March 29, 2012

Study Record Updates

Last Update Posted (Estimate)

October 15, 2012

Last Update Submitted That Met QC Criteria

October 12, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1128-4677

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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