NCT01566734

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 29, 2012

Completed
Last Updated

October 15, 2012

Status Verified

October 1, 2012

Enrollment Period

1 year

First QC Date

March 26, 2012

Last Update Submit

October 12, 2012

Conditions

Surgical Site Infections

Keywords

Surgical Wound InfectioncefazolinCesarean Section

Outcome Measures

Primary Outcomes (1)

  • SSI

    one week after discharge

Study Arms (3)

Cefazolin

EXPERIMENTAL

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

Normal Saline

EXPERIMENTAL

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

Other: Normal Saline Irrigation

Control

NO INTERVENTION

Interventions

Cefazolin irrigationOTHER

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

Also known as: cephazolin, cefazoline, Ancef, Cefacidal, Cefamezin, Cefrina, Elzogram, Faxilen, Gramaxin, Kefazol, Kefol, Kefzolan, Kezolin, Novaporin, Reflin, Zinol, Zolicef
Cefazolin
Normal Saline IrrigationOTHER

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

Also known as: sodium chloride, saline solution
Normal Saline

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • pregnant women
  • hours passed their rupture of membrane
  • needed to undergo cesarean

You may not qualify if:

  • allergy to penicillin
  • allergy to cefazolin
  • history of immunosuppressive drug use
  • gestational diabetes mellitus
  • preeclampsia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shariati Hospital

Bandar Abbas, Hormozgan, 79176, Iran

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

CefazolinSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Maryam Rahmani, MD

    Hormozgan University of Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mohammad Esmaeil Shahrzad

Study Record Dates

First Submitted

March 26, 2012

First Posted

March 29, 2012

Study Start

December 1, 2010

Primary Completion

December 1, 2011

Study Completion

February 1, 2012

Last Updated

October 15, 2012

Record last verified: 2012-10

Locations

IR(1)