To Assess Use of Vancomycin Powder in Craniotomy on Wound Infection Rates

NCT04917627 | Unknown Phase 4

• 1 other identifier: MRC-01-18-220
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical site infection (SSI) after craniotomy is a major cause of morbidity and mortality besides its major health care cost. In each hospital, all measures are taken to decrease SSI. Despite current prophylactic measures, rates of SSIs have been reported in up to 5% of patients post craniotomy. Intrawound vancomycin powder has been studied extensively in spinal fusion surgeries and been found to reduce rates of surgical site infections (SSIs) significantly. Despite its success in spinal surgeries, topical vancomycin has not been extensively studied with respect to cranial neurosurgery. The use of adjuvant vancomycin powder was associated with a significant reduction in the incidence of postoperative infection as well as infection-related medical costs. These findings suggest that the use of adjuvant vancomycin powder in high-risk patients undergoing spinal fusion is a cost-saving option for preventing postoperative infections, as it can lead to cost-savings of $438,165 per 100 spinal fusions performed. The investigators believe that Topical vancomycin is a safe, effective, and cost-saving measure to prevent SSIs following craniotomy.

Conditions

Wound Infection

Outcome Measures

Primary Outcomes (1)

• rate of wound infection

  to assess the effectiveness of vancomycin in craniotomy on the surgical site infection rate as compared to controls.

  24 months

Secondary Outcomes (1)

• asses the rate wound complication

  24 months

Study Arms (2)

vancomycin group (intervention arm)

ACTIVE COMPARATOR

We will use one vial of vancomycin that contains 1000 mg of the drug in powder form on the surgical site before closing the wound

Drug: Vancomycin

control group

NO INTERVENTION

no vancomycin powder will be used

Interventions

Vancomycin DRUG

one vial of vancomycin (1000 mg ) powder form.

Also known as: vancomax 1000mg powder form, KULLANMA TALİMATI

vancomycin group (intervention arm)

Eligibility Criteria

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

You may qualify if:

• Any type of craniotomy whatever the cause.
• Age more than 18 Years
• Patient with no evidence of any source of infection

You may not qualify if:

• Any evidence of infection.
• Age less than 18 years
• Previous and multiple craniotomies
• Active infection
• Craniectomy
• wound laceration over the craniotomy site.

Sponsors & Collaborators

• Hamad General Hospital: lead

Study Sites (1)

Hamad General Hospital

Doha, Qatar

RECRUITING

MeSH Terms

Conditions

Wound Infection

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• sirajeddin belkhair

  Hamad General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

sirajeddin belkhair

CONTACT

+97466349091; sbelkhair@hamad.qa

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department, neurosurgery, neuroscience institute

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: June 8, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)