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

Wound Infection Clinical Trial

Official title:

Randomized Controlled Trial Assessing Use of Vancomycin Powder in Craniotomy on Wound Infection Rates

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04917627
• Other study ID #: MRC-01-18-220
• Status: Recruiting
• Phase: Phase 4
• Start date: May 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: June 2021
• Source: Hamad General Hospital
• Contact: sirajeddin belkhair
• Phone: +97466349091
• Email: sbelkhair[@]hamad.qa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Wound Infection
• Wounds and Injuries

Intervention

Drug:
• Vancomycin
one vial of vancomycin (1000 mg ) powder form.

Locations

Country	Name	City	State
Qatar	Hamad General Hospital	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Hamad General Hospital

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	asses the rate wound complication	to assess the complications of intrawound vancomycin like seroma , long term benefit and cost effectiveness of vancomycin use on hospital stay and patient recovery, and to look for any other infection at 3 months follow up.	24 months