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

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ClinicalTrials.gov Identifier: NCT01566734
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : October 15, 2012
Sponsor:
Information provided by (Responsible Party):
Mohammad E Shahrzad, MD, Hormozgan University of Medical Sciences

Brief Summary:

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 or disease Intervention/treatment Phase
Surgical Site Infections Other: Cefazolin irrigation Other: Normal Saline Irrigation Not Applicable

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  (Clinical Trial)
Actual Enrollment : 200 participants
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
Study Start Date : December 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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


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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

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

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 Posted: March 29, 2012    Key Record Dates
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