Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04917627
Other study ID # MRC-01-18-220
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT02905955 - Vacuumtherapy After Venous Hybrid Procedures Phase 4
Not yet recruiting NCT02868372 - Swabbing of Subcutaneous Tissues of Cesarean Section Wounds With Povidone Iodine N/A
Enrolling by invitation NCT02559453 - Outcomes for 2 Operations Versus ≥ 3 Operations in Infected Wounds N/A
Completed NCT02744144 - Wound Bacterial Microbiota and Their Antibiotic Resistance N/A
Active, not recruiting NCT01939145 - Comparing Outcomes for Prontosan Versus Normal Saline for Negative Pressure Wound Therapy With Instillation Phase 4
Completed NCT00998907 - PDS*Plus and Wound Infections After Laparotomy N/A
Completed NCT01141335 - Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair Phase 4
Completed NCT00576745 - A Comparison Of The 3M TM S Surgical Skin Closure System To The Standard Vicryl Suture Closure of Sternotomy Incisions During Cardiac Surgery Phase 1
Terminated NCT00654641 - Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy N/A
Completed NCT00402727 - Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection Phase 3
Recruiting NCT00150852 - Prevention of Gastrostomy-Related Wound Infection by Vancomycin in Carriers of Methicillin-Resistant Staphylococcus Aureus. Phase 2
Not yet recruiting NCT03872544 - Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Recruiting NCT04596124 - Effectiveness and Tolerability of Fitostimoline Plus Cream and Gauze vs Connettivina Bio Plus Cream and Gauze N/A
Active, not recruiting NCT04584957 - Prophylactic Negative Pressure Wound Therapy (VAC) in Gynecologic Oncology (G.O.) N/A
Recruiting NCT03960970 - Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries Phase 2
Enrolling by invitation NCT03880188 - Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Completed NCT02018094 - The Amputation Surgical Site Infection Trial (ASSIT) Phase 4
Terminated NCT03269968 - Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery N/A
Enrolling by invitation NCT02945761 - High Concentration of Sugar Solution Irrigation Promotes the Healing of Infected Wound N/A
Not yet recruiting NCT02882360 - Kerlix for Pregnant Women With Elevated BMI to Prevent Wound Infection by 6 Weeks Post Partum Phase 4