NCT05398081

Cefuroxime vs Ceftriaxone for SSI Prevention in Neurosurgery

Completed Phase 2 Last updated 26 May 2023

What this trial tests

Phase 2 trial testing Cefuroxime (Zinnat®) in Surgical Site Infection in 96 participants. Completed in 5 March 2022.

Timeline

1 December 2021

Primary endpoint
6 February 2022

5 March 2022

Quick facts

Lead sponsor	Dr. Promise Tamunoipiriala Jaja
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	96
Start date	1 December 2021
Primary completion	6 February 2022
Estimated completion	5 March 2022
Sites	1 location across Nigeria

Drugs / interventions tested

• Cefuroxime (Zinnat®) — full drug profile →
• Ceftriaxone (Rocephin®) — full drug profile →

Conditions studied

• Surgical Site Infection — all drugs for Surgical Site Infection →
• Antibiotics Prophylaxis — all drugs for Antibiotics Prophylaxis →

Sponsor

Dr. Promise Tamunoipiriala Jaja

Who can join

Eligibility, any sex, with Surgical Site Infection or Antibiotics Prophylaxis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.