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

NCT ID: NCT01566734

Last Updated: 2012-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Surgical Site Infections

Keywords

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Surgical Wound Infection cefazolin Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Cefazolin irrigation

Intervention Type OTHER

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

after the surgery and before closing up the patients, 150 cc of normal saline was used to irrigate the patients

Group Type EXPERIMENTAL

Normal Saline Irrigation

Intervention Type OTHER

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

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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cephazolin cefazoline Ancef Cefacidal Cefamezin Cefrina Elzogram Faxilen Gramaxin Kefazol Kefol Kefzolan Kezolin Novaporin Reflin Zinol Zolicef sodium chloride saline solution

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hormozgan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Mohammad E Shahrzad, MD

Mohammad Esmaeil Shahrzad

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maryam Rahmani, MD

Role: STUDY_DIRECTOR

Hormozgan University of Medical Sciences

Locations

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Shariati Hospital

Bandar Abbas, Hormozgan, Iran

Site Status

Countries

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Iran

Other Identifiers

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U1111-1128-4677

Identifier Type: -

Identifier Source: org_study_id