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

Surgical Site Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01566734
• Other study ID #: U1111-1128-4677
• Status: Completed
• Phase: N/A
• First received: March 26, 2012
• Last updated: October 12, 2012
• Start date: December 2010
• Est. completion date: February 2012

Study information

• Verified date: October 2012
• Source: Hormozgan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Site Infections
• Surgical Wound Infection

Intervention

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
• 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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shariati Hospital	Bandar `Abbas	Hormozgan

Sponsors (1)

Lead Sponsor	Collaborator
Hormozgan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SSI		one week after discharge	No