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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01566734
First Posted: March 29, 2012
Last Update Posted: October 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mohammad E Shahrzad, MD, Hormozgan University of Medical Sciences
  Purpose

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.


Condition Intervention
Surgical Site Infections Other: Cefazolin irrigation Other: Normal Saline Irrigation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Comparison of the Effect of Cefazolin and Normal Saline Irrigation With no Irrigation on the Incidence of Surgical Site Infections

Resource links provided by NLM:


Further study details as provided by Mohammad E Shahrzad, MD, Hormozgan University of Medical Sciences:

Primary Outcome Measures:
  • SSI [ Time Frame: one week after discharge ]

Enrollment: 200
Study Start Date: December 2010
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • cephazolin
  • cefazoline
  • Ancef
  • 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
No Intervention: Control

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566734


Locations
Iran, Islamic Republic of
Shariati Hospital
Bandar `Abbas, Hormozgan, Iran, Islamic Republic of, 79176
Sponsors and Collaborators
Hormozgan University of Medical Sciences
Investigators
Study Director: Maryam Rahmani, MD Hormozgan University of Medical Sciences
  More Information

Responsible Party: Mohammad E Shahrzad, MD, Mohammad Esmaeil Shahrzad, Hormozgan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01566734     History of Changes
Other Study ID Numbers: U1111-1128-4677
First Submitted: March 26, 2012
First Posted: March 29, 2012
Last Update Posted: October 15, 2012
Last Verified: October 2012

Keywords provided by Mohammad E Shahrzad, MD, Hormozgan University of Medical Sciences:
Surgical Wound Infection
cefazolin
Cesarean Section

Additional relevant MeSH terms:
Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents