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NCT06048692 Clinical Trial

Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections

Cesarean Section; Infection Clinical Trial

Official title:
The Impact of Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06048692
Other study ID # maxipime in cs
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date January 1, 2023
Est. completion date September 20, 2023

Study information
Verified date September 2023
Source Beni-Suef University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the aim of this study is to evaluate the efficacy of employing cefepime (CFM) versus ampicillin/sulbactam (AMS) in lowering the rate of post-cesarean surgical site infections.

Description:

A prospective randomized clinical study conducted in the department of obstetrics and gynecology of Beni-Suef University Hospital . A total of 213 women were assessed for eligibility, 13 of which were excluded. A total of 200 pregnant women who were eligible for elective cesarean sections (CS). The overall median duration of postoperative followed up was from 10 days to one month to determine the surgical site infection (SSI).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 213
Est. completion date September 20, 2023
Est. primary completion date September 15, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Pregnant women within age group more than18 years. - Pregnant women with elective cesarean delivery. - Previous and primary cesarean delivery. Exclusion Criteria: Severe hepatic disease women Emergent cesarean deliveries. Women with medical disorders as pre-gestational diabetes, anemia, hypertension, or preeclampsia. Women who had a skin infection adjacent to the operative site.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cefepime 1000 MG
Cefepime is a fourth-generation cephalosporin antibiotic
• Ampicillin-sulbactam
Broad-Spectrum Antibiotic

Locations
Country Name City State
Egypt Beni-suef university Hospital Bani Suwayf Beni Suef

Sponsors (1)
Lead Sponsor Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary surgical site infection pain, redness, swelling, warm skin around the wound, yellow or green discharge 1 month
See also
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