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

NCT ID: NCT04917627

Last Updated: 2021-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-05-01

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.

Detailed Description

its Prospective Randomized clinical trial. The investigator will do block randomization that is done by a biostatistician through SAS software . Patients will be divided in this Trial into two groups, first group (intervention arm) they will receive the drug (vancomycin). The second group (control arm) they will not receive the drug, otherwise both groups they will receive identical measure to decrease the postoperative SSI.

The investigator will use one vial of vancomycin that contains 1000 mg of the drug in the powder form.

The primary outcome variable will be SSI rate factored by cohort. Secondary outcome will be cost savings from vancomycin usage estimated from hospital costs associated with SSI in craniotomy patients, morbidity and mortality.

SSI found to be around 0.49% when vancomycin was used, while SSI in standard care found to be 5%, to get power of study 80% and level of significance 5%. Sample size will be 250 in each group using sample size calculator.

The statistical formula used in computation of required and adequate sample size in view of primary outcome i.e., SSI rate between the two groups:

The sample size was computed using the following statistical formula and sample size determination equation:

n = (Zα/2+Zβ)2 * (p1(1-p1)+p2(1-p2)) / (p1-p2)2

Where Zα/2 is the critical value of the Normal distribution at α/2 (e.g. for a confidence level of 95%, α is 0.05 and the critical value is 1.96), Zβ is the critical value of the Normal distribution at β (e.g. for a power of 80%, β is 0.2 and the critical value is 0.84) and p1 and p2 are the expected sample proportions of the two groups (SSI rate between the two groups i.e., vancomycin and control groups).

Before the study starts the investigator will do automated coded file with each code randomized to either arm (intervention arm and regular arm), then patient will be assigned to subsequent arm according to the code. CONSORT guidelines will be followed when reporting the results of the trail.

Conditions

Wound Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

vancomycin group (intervention arm)

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

Group Type: ACTIVE_COMPARATOR

Vancomycin

Intervention Type: DRUG

one vial of vancomycin (1000 mg ) powder form.

control group

no vancomycin powder will be used

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vancomycin

one vial of vancomycin (1000 mg ) powder form.

Intervention Type: DRUG

Other Intervention Names

vancomax 1000mg powder form, KULLANMA TALİMATI

Eligibility Criteria

Inclusion Criteria

1. Any type of craniotomy whatever the cause.

2. Age more than 18 Years

3. Patient with no evidence of any source of infection

Exclusion Criteria

1. Any evidence of infection.

2. Age less than 18 years

3. Previous and multiple craniotomies

4. Active infection

5. Craniectomy

6. wound laceration over the craniotomy site.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hamad General Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. sirajeddin belkhair

Head of department, neurosurgery, neuroscience institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sirajeddin belkhair

Role: PRINCIPAL_INVESTIGATOR

Hamad General Hospital

Locations

Hamad General Hospital

Doha, , Qatar

Site Status: RECRUITING

Countries

Qatar

Central Contacts

sirajeddin belkhair

Role: CONTACT

sbelkhair@hamad.qa

+97466349091

Facility Contacts

sirajeddin belkhair

Role: primary

sbelkhair@hamad.qa

+97466349091

Other Identifiers

MRC-01-18-220

Identifier Type: -

Identifier Source: org_study_id