Back to resultsAntibiotics for Prevention of SSI in Obese Women Undergoing CS
Primary Purpose
Surgical Site Infection
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cephalexin
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infection
Eligibility Criteria
Inclusion Criteria:
- obese women under elective CS
Exclusion Criteria:
- immunodeficient women
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cephalexin
Cephalexin &metronidazole
Arm Description
Group a will receive cephalexin 1gm before skin incision intravenous
Group b will receive cephalexin 1gm intravenous plus 1gm metronidazole rectally before skin incision
Outcomes
Primary Outcome Measures
Wound infection
Fever, redness, ecchymosis and tenderness
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03736187
Brief Title
Antibiotics for Prevention of SSI in Obese Women Undergoing CS
Official Title
Combination Vs Single Antibiotics for Prevention of SSI in Obese Women Undergoing CS
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2019 (Anticipated)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Effect of cephalexin plus metronidazole on SSI better than cephalexin alone in obese women undergoing CS
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 Groups of obese women under elective cesarean section
Masking
Participant
Masking Description
Two equal groups,140 women in each group
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cephalexin
Arm Type
Experimental
Arm Description
Group a will receive cephalexin 1gm before skin incision intravenous
Arm Title
Cephalexin &metronidazole
Arm Type
Experimental
Arm Description
Group b will receive cephalexin 1gm intravenous plus 1gm metronidazole rectally before skin incision
Intervention Type
Drug
Intervention Name(s)
Cephalexin
Other Intervention Name(s)
Metronidazole
Intervention Description
Giving cephalexin and metronidazole in one group &cephalexin alone in another group
Primary Outcome Measure Information:
Title
Wound infection
Description
Fever, redness, ecchymosis and tenderness
Time Frame
One week
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
obese women under elective CS
Exclusion Criteria:
immunodeficient women
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Antibiotics for Prevention of SSI in Obese Women Undergoing CS
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