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

Primary Purpose

Surgical Site Infections

Status

Completed

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Cefazolin irrigation

Normal Saline Irrigation

About this trial

This is an interventional prevention trial for Surgical Site Infections focused on measuring Surgical Wound Infection, cefazolin, Cesarean Section

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Shariati Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Cefazolin

Normal Saline

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

SSI

Secondary Outcome Measures

Full Information

NCT ID

NCT01566734

First Posted

March 26, 2012

Last Updated

October 12, 2012

Sponsor

Hormozgan University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01566734

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hormozgan University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgical Site Infections

Keywords

Surgical Wound Infection, cefazolin, Cesarean Section

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cefazolin

Arm Type

Experimental

Arm Description

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

Arm Title

Normal Saline

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

Cefazolin irrigation

Other Intervention Name(s)

cephazolin, cefazoline, Ancef, Cefacidal, Cefamezin, Cefrina, Elzogram, Faxilen, Gramaxin, Kefazol, Kefol, Kefzolan, Kezolin, Novaporin, Reflin, Zinol, Zolicef

Intervention Description

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

Intervention Name(s)

Normal Saline Irrigation

Other Intervention Name(s)

sodium chloride, saline solution

Intervention Description

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

Primary Outcome Measure Information:

Title

SSI

Time Frame

one week after discharge

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maryam Rahmani, MD

Organizational Affiliation

Hormozgan University of Medical Sciences

Official's Role

Study Director

Facility Information:

Facility Name

Shariati Hospital

City

Bandar 'Abbas

State/Province

Hormozgan

ZIP/Postal Code

79176

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

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

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