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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mohammad E Shahrzad, MD, Hormozgan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01566734
First received: March 26, 2012
Last updated: October 12, 2012
Last verified: October 2012
History of Changes
  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 Blind (Subject)
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:

U.S. FDA Resources

Further study details as provided by Hormozgan University of Medical Sciences:

Primary Outcome Measures:
  • SSI [ Time Frame: one week after discharge ] [ Designated as safety issue: No ]

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

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 26, 2012
Last Updated: October 12, 2012
Health Authority: Iran: Ministry of Health

Keywords provided by Hormozgan University of Medical Sciences:
Surgical Wound Infection
cefazolin
Cesarean Section

Additional relevant MeSH terms:
Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013