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Antibiotics for Prevention of SSI in Obese Women Undergoing CS

Sponsor
Ain Shams University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03736187
Collaborator
(none)
280
Enrollment
2
Arms
8
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
280 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
2 Groups of obese women under elective cesarean section2 Groups of obese women under elective cesarean section
Masking:
Single (Participant)
Masking Description:
Two equal groups,140 women in each group
Primary Purpose:
Prevention
Official Title:
Combination Vs Single Antibiotics for Prevention of SSI in Obese Women Undergoing CS
Anticipated Study Start Date :
Apr 1, 2019
Anticipated Primary Completion Date :
Oct 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Wound infection [One week]

      Fever, redness, ecchymosis and tenderness

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • obese women under elective CS
    Exclusion Criteria:
    • immunodeficient women

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abeer mohammed abd allah elsayed, Cairo governorate,hadaik elqoba,elkhalig elmasry street, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT03736187
    Other Study ID Numbers:
    • Antibiotics for SSI
    First Posted:
    Nov 9, 2018
    Last Update Posted:
    Nov 9, 2018
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Surgical Wound Infection
    Metronidazole
    Cephalexin

    Study Results

    No Results Posted as of Nov 9, 2018