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

• Sponsor: Hormozgan University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT01566734
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 3
• Duration (Months): 14
• Patients Per Site Per Month: 14.3

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Dec 1, 2010
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. SSI [one week after discharge]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohammad E Shahrzad, MD, Mohammad Esmaeil Shahrzad, Hormozgan University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT01566734
• Other Study ID Numbers: U1111-1128-4677
• First Posted: Mar 29, 2012
• Last Update Posted: Oct 15, 2012
• Last Verified: Oct 1, 2012

• Keywords provided by Mohammad E Shahrzad, MD, Mohammad Esmaeil Shahrzad, Hormozgan University of Medical Sciences: Surgical Wound Infection; cefazolin; Cesarean Section
• Additional relevant MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection; Cefazolin

Study Results

No Results Posted as of Oct 15, 2012