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Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06048692
Enrollment
213
Registered
2023-09-21
Start date
2023-01-01
Completion date
2023-09-20
Last updated
2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section; Infection

Keywords

surgical site infection, Cefepime

Brief 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.

Detailed 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).

Interventions

DRUGCefepime 1000 MG

Cefepime is a fourth-generation cephalosporin antibiotic

Broad-Spectrum Antibiotic

Sponsors

Beni-Suef University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
surgical site infection1 monthpain, redness, swelling, warm skin around the wound, yellow or green discharge

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026