Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections

Sponsor

Beni-Suef University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06048692

Collaborator

(none)

213

Enrollment

Location

Arms

8.6

Anticipated Duration (Months)

24.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section; Infection	Drug: Cefepime 1000 MG Drug: Ampicillin-sulbactam	Phase 3

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

213 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2023

Actual Primary Completion Date :

Sep 15, 2023

Anticipated Study Completion Date :

Sep 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cefepime Group Pregnant women (n=100) received IV cefepime (CEF) (maxipime®1000mg) 30 minutes before cesarean delivery (CD) and 12 hours after CD	Drug: Cefepime 1000 MG Cefepime is a fourth-generation cephalosporin antibiotic Other Names: maxipime
Active Comparator: Ampicillin/Sulbactam Pregnant women (n=100) received IV Ampicillin/Sulbactam (AMS) (Unictam® 1500 mg) 30 minutes before CD and 12 hours after CD	Drug: Ampicillin-sulbactam Broad-Spectrum Antibiotic Other Names: unictam

Arm

Intervention/Treatment

Experimental: Cefepime Group

Pregnant women (n=100) received IV cefepime (CEF) (maxipime®1000mg) 30 minutes before cesarean delivery (CD) and 12 hours after CD

Drug: Cefepime 1000 MG

Cefepime is a fourth-generation cephalosporin antibiotic

Other Names:

maxipime

Active Comparator: Ampicillin/Sulbactam

Pregnant women (n=100) received IV Ampicillin/Sulbactam (AMS) (Unictam® 1500 mg) 30 minutes before CD and 12 hours after CD

Drug: Ampicillin-sulbactam

Broad-Spectrum Antibiotic

Other Names:

unictam

Outcome Measures

Primary Outcome Measures

surgical site infection [1 month]
pain, redness, swelling, warm skin around the wound, yellow or green discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beni-suef university Hospital	Banī Suwayf	Beni Suef	Egypt	62521

Sponsors and Collaborators

Beni-Suef University

Investigators

Principal Investigator: Beni-Suef University, Faculty of Medicine Beni-Suef University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sara Abdallah Mohamed Salem, principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University, Beni-Suef University

ClinicalTrials.gov Identifier:

NCT06048692

Other Study ID Numbers:

maxipime in cs

First Posted:

Sep 21, 2023

Last Update Posted:

Sep 21, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sara Abdallah Mohamed Salem, principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University, Beni-Suef University

surgical site infection

Cefepime

Additional relevant MeSH terms:

Infections

Communicable Diseases

Surgical Wound Infection

Study Results

No Results Posted as of Sep 21, 2023