Cefuroxime vs Ceftriaxone for SSI Prevention in Neurosurgery

NCT05398081 | Completed Phase 2 DMC

• 1 other identifier: UI/EC/21/0099
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Surgical site infection; Antibiotics prophylaxis; Cefuroxime; Ceftriaxone; Craniotomy; Laminectomy

Outcome Measures

Primary Outcomes (2)

• Surgical site infection

  The presence or absence surgical site infection

  Six weeks

• Types and number of organism(s) causing surgical site infection

  The organisms isolated following culture of samples from an area of surgical site infection will be identified and a count will be made.

  Six weeks

Secondary Outcomes (1)

• Cost of care

  Six weeks

Study Arms (2)

Cefuroxime

EXPERIMENTAL

Cefuroxime (Zinnat®) will be used as prophylactic antibiotic in this arm

Drug: Cefuroxime (Zinnat®)

Ceftriaxone

ACTIVE COMPARATOR

Ceftriaxone (Rocephin®) will be used as prophylactic antibiotic in this arm

Drug: Ceftriaxone (Rocephin®)

Interventions

Cefuroxime (Zinnat®) DRUG

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

Cefuroxime

Ceftriaxone (Rocephin®) DRUG

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

Ceftriaxone

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients scheduled for clean and clean-contaminated neurosurgical procedures that consent to participating in the study.

You may not qualify if:

• Patients with contaminated and dirty wounds e.g. grossly contaminated open depressed skull fracture, cranial endonasal surgeries and so on.
• Patients who has had systemic antibiotic therapy within 7 days before surgery.
• Patients with diabetes mellitus.
• Patients with implants (they will need longer follow up).
• Allergy to cephalosporins
• Infectious disease such as brain abscess, subdural empyema, osteitis and scalp infection

Sponsors & Collaborators

• Dr. Promise Tamunoipiriala Jaja: lead

Study Sites (1)

University College Hospital

Ibadan, Oyo State, 5116, Nigeria

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Cefuroxime; cefuroxime axetil; Ceftriaxone

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cefotaxime; Cephacetrile

Study Officials

• Oghenekevwe E Okere, MBBS

  University College Hospital, Ibadan

  PRINCIPAL INVESTIGATOR

• Amos O Adeleye, FWACS, FACS

  University College Hospital, Ibadan

  STUDY DIRECTOR

• Augustine A Adeolu, FWACS

  University College Hospital, Ibadan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 26, 2021
• First Posted: May 31, 2022
• Study Start: December 1, 2021
• Primary Completion: February 6, 2022
• Study Completion: March 5, 2022
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: About the year following completion of the study
• Access Criteria: Access will be granted following request for permissions

Locations

NG (1)