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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Wound Infection
• Intervention / Treatment: Drug: Vancomycin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: sirajeddin belkhair; Phone Number: +97466349091; Email: sbelkhair@hamad.qa

Study Locations

• Qatar
  • Doha, Qatar
    • Recruiting
    • Hamad General Hospital
    • Contact: sirajeddin belkhair; Phone Number: +97466349091; Email: sbelkhair@hamad.qa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Vancomycin; one vial of vancomycin (1000 mg ) powder form.; Other Names: vancomax 1000mg powder form, KULLANMA TALİMATI
No Intervention: control group; no vancomycin powder will be used

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hamad General Hospital
• Investigators: Principal Investigator: sirajeddin belkhair, Hamad General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Wound Infection; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: MRC-01-18-220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No