Antibiotics for Prevention of SSI in Obese Women Undergoing CS

November 7, 2018 updated by: Abeer mohammed abd allah elsayed, Ain Shams University

Combination Vs Single Antibiotics for Prevention of SSI in Obese Women Undergoing CS

Effect of cephalexin plus metronidazole on SSI better than cephalexin alone in obese women undergoing CS

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Comparison between efficacy of cephalexin alone and cephalexin plus metronidazole on surgical site infection in obese women undergoing CS and follow up of any signs of wound infection

Study Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • obese women under elective CS

Exclusion Criteria:

  • immunodeficient women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cephalexin
Group a will receive cephalexin 1gm before skin incision intravenous
Drug: Cephalexin
Giving cephalexin and metronidazole in one group &cephalexin alone in another group
Other Names:
  • Metronidazole
EXPERIMENTAL: Cephalexin &metronidazole
Group b will receive cephalexin 1gm intravenous plus 1gm metronidazole rectally before skin incision
Drug: Cephalexin
Giving cephalexin and metronidazole in one group &cephalexin alone in another group
Other Names:
  • Metronidazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound infection
Time Frame: One week
Fever, redness, ecchymosis and tenderness
One week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2019

Primary Completion (ANTICIPATED)

October 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

March 27, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (ACTUAL)

November 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2018

Last Update Submitted That Met QC Criteria

November 7, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Antibiotics for SSI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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