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Cefuroxime vs Ceftriaxone for SSI Prevention in Neurosurgery

NCT05398081 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-05-26

No results posted yet for this study

Summary

BACKGROUND: Surgical site infection (SSI) is potentially catastrophic in neurosurgical procedures, causing poor in-hospital outcomes in more than half of those affected and significantly increased length of hospital stay. The appropriate and timely use of prophylactic antibiotics is found to reduce the prevalence of SSIs. At present, several regimen of antimicrobial agents are used in neurosurgical procedures since the choice of appropriate antibiotic agent is not fully established. Cephalosporins are among the frequently used antibiotics for prophylaxis in neurosurgical procedures, with studies comparing first and second generation Cephalosporins to third generation in neurosurgical prophylaxis, showing no superiority of the latter over the former. Clearly, comparing Cefuroxime (a second generation Cephalosporin) to Ceftriaxone (a third generation Cephalosporin) in neurosurgical procedures will provide more knowledge on the efficacy of Cefuroxime as antibiotics prophylaxis.

OBJECTIVE: The study aimed to determine the comparative efficacy of cefuroxime versus ceftriaxone in the prevention of surgical site infection after neurosurgical procedures at the University College Hospital Ibadan, Nigeria.

METHODS: The study will be a randomized controlled trial recruiting 92 participants. Participants would be patients undergoing neurosurgical procedures; they will be randomized to treatment arms (those receiving cefuroxime versus ceftriaxone for antibiotic prophylaxis). All the study articipants will be followed up for 30 days to assess for the development of surgical site infection.

DATA ANALYSIS: Data will be collated, computed and analyzed using the Statistical Product and Service Solutions (SPSS) Version 21. Demographics will be presented using summary statistics; mean +/- standard deviation and figures (e.g pie chart, histogram). Study outcomes will yield categorical and continuous variables which will be analyzed using chi-squared test and Z-test and/or T-test for hypothesis testing.

Conditions

  • Surgical Site Infection
  • Antibiotics Prophylaxis

Interventions

DRUG

Cefuroxime (Zinnat®)

Antibiotic for prophylaxis against surgical site infection following craniotomy and laminectomy Here, Cefuroxime (Zinnat®), a second generation cephalosporin will be used

DRUG

Ceftriaxone (Rocephin®)

Antibiotic for prophylaxis against surgical site infection following craniotomy and laminectomy Here, Ceftriaxone (Rocephin®) a third generation cephalosporin will be used

Sponsors & Collaborators

  • Dr. Promise Tamunoipiriala Jaja

    lead OTHER

Principal Investigators

  • Oghenekevwe E Okere, MBBS · University College Hospital, Ibadan

  • Amos O Adeleye, FWACS, FACS · University College Hospital, Ibadan

  • Augustine A Adeolu, FWACS · University College Hospital, Ibadan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-02-06
Completion
2022-03-05

Countries

  • Nigeria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05398081 on ClinicalTrials.gov