Wound InfectionPhase 4NCT04917627
To Assess Use of Vancomycin Powder in Craniotomy on Wound Infection Rates
A Phase 4 study testing Vancomycin in people with Wound Infection, run by Hamad General Hospital at 1 site in Qatar.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound Infection
- What is being tested?
- Vancomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteQatar
- Study dates
- 1 May 2021to 1 May 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any type of craniotomy whatever the cause.
- Age more than 18 Years
- Patient with no evidence of any source of infection
Who cannot join
- Any evidence of infection.
- Age less than 18 years
- Previous and multiple craniotomies
- Active infection
- Craniectomy
- wound laceration over the craniotomy site.
Trial locations and contacts
1 site in 1 country.
Qatar1 site, 1 recruiting
- Recruiting
Hamad General Hospital
Doha
sirajeddin belkhair, +97466349091, sbelkhair@hamad.qa
About this study
Official title: 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.
Read the 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
- Being tested
- Vancomycin
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Also called vancomax 1000mg powder form, KULLANMA TALİMATI
one vial of vancomycin (1000 mg ) powder form.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Vancomycin |
| control group | No intervention | no vancomycin powder will be used |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of wound infection
to assess the effectiveness of vancomycin in craniotomy on the surgical site infection rate as compared to controls.
Measured: 24 months
Secondary outcomes (1)
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start1 May 2021
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. sirajeddin belkhair, Hamad General Hospital
- Investigators
- sirajeddin belkhair, Principal investigator, Hamad General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917627
- Sponsor's protocol ID
- MRC-01-18-220
- Status last verified
- Jun 2021
- First submitted
- 21 May 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Assessing Use of Vancomycin Powder in Craniotomy on Wound Infection Rates
- ClinicalTrials.gov ID
- NCT04917627
- Acronym / sponsor ID
- MRC-01-18-220
- Conditions
- Wound Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hamad General HospitalOther government
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vancomycin group (intervention arm) | Active comparator | Drug: VancomycinWe will use one vial of vancomycin that contains 1000 mg of the drug in powder form on the surgical site before closing the wound |
| control group | No intervention | –no vancomycin powder will be used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any type of craniotomy whatever the cause.
- Age more than 18 Years
- Patient with no evidence of any source of infection
Key exclusion criteria (6 listed)
- Any evidence of infection.
- Age less than 18 years
- Previous and multiple craniotomies
- Active infection
- Craniectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VancomycinAlso: vancomax 1000mg powder form, KULLANMA TALİMATIone vial of vancomycin (1000 mg ) powder form. | Drug | vancomycin group (intervention arm) |
Primary outcome
rate of wound infection
Time frame: 24 months
to assess the effectiveness of vancomycin in craniotomy on the surgical site infection rate as compared to controls.
1 secondary outcome
asses the rate wound complication
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sirajeddin belkhair principal investigator
Hamad General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vancomycin in people with Wound Infection, run by Hamad General Hospital at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sirajeddin belkhair (+97466349091, sbelkhair@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of wound infection (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.