NCT03736187

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

March 27, 2018

Completed
8 months until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 9, 2018

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

March 27, 2018

Last Update Submit

November 7, 2018

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

  • Wound infection

    Fever, redness, ecchymosis and tenderness

    One week

Study Arms (2)

Cephalexin

EXPERIMENTAL

Group a will receive cephalexin 1gm before skin incision intravenous

Drug: Cephalexin

Cephalexin &metronidazole

EXPERIMENTAL

Group b will receive cephalexin 1gm intravenous plus 1gm metronidazole rectally before skin incision

Drug: Cephalexin

Interventions

CephalexinDRUG

Giving cephalexin and metronidazole in one group \&cephalexin alone in another group

Also known as: Metronidazole
CephalexinCephalexin &metronidazole

Eligibility Criteria

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

You may qualify if:

  • obese women under elective CS

You may not qualify if:

  • immunodeficient women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

CephalexinMetronidazole

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNitroimidazolesNitro CompoundsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Two equal groups,140 women in each group
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 2 Groups of obese women under elective cesarean section
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cairo governorate,hadaik elqoba,elkhalig elmasry street

Study Record Dates

First Submitted

March 27, 2018

First Posted

November 9, 2018

Study Start

April 1, 2019

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

November 9, 2018

Record last verified: 2018-11