Surgical Site Infection Clinical Trial
— VADEROfficial title:
Vacuum Drains vs Passive Drains vs no Drains in Decompressive Craniectomies - A Randomized Controlled Trial on Subgaleal Drain Complication Rates
NCT number | NCT03777774 |
Other study ID # | VADER 1.0 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2019 |
Est. completion date | June 30, 2020 |
Verified date | May 2021 |
Source | Universiti Sains Malaysia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research is about the use of subgaleal drains to prevent accumulation of blood under the skin in patients undergoing surgery to remove part of the skull(craniectomy) and its associated complications. There have been early research that shows usage of subgaleal drains maybe related to increase in complication rates after craniectomy. These complications include hydrocephalus (accumulation of fluid in the brain), new hemorrhages, infection and low blood pressure. The investigators are performing this research to determine which type of subgaleal drains would produce the least complications. With this knowledge, the investigators would be able to reduce the amount of complications for future patients that undergo surgery to remove part of the skull. The purpose of this study is to determine the rate of complications in the 3 different groups of patients using the different types of drains under the skin in surgeries that involve removal of part of the skull. All participants will undergo the required surgery to remove part of the skull (craniectomy). Participants will then be randomly assigned to either one of 3 groups which are the vacuum drain group, passive drain group or no drain group.Participants in the vacuum drain group will have vacuum drains inserted during the closing stage of the surgery. Participants in the passive drain group will have passive drains inserted during the closing stage of the surgery. Participants in the no drain group will have a drain inserted during the closing stage of the procedure but the drain will remained closed. Data will then be collected and analysed to determine if the type of drains influence the rate of complications in craniectomy
Status | Completed |
Enrollment | 78 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 80 Years |
Eligibility | Inclusion Criteria: - patients with indication for decompressive craniectomy as decided by the neurosurgeon in-charge. Indications maybe for traumatic intracranial bleed, spontaneous intracranial bleed and malignant middle cerebral artery territory infarction - Written informed consent by legal representative of patient Exclusion Criteria: - history of recent antiplatelet or anticoagulant use - patients with evidence of coagulopathy or thrombocytopenia from lab results - possible disseminated intravascular coagulation preoperatively - Presence of hydrocephalus preoperatively |
Country | Name | City | State |
---|---|---|---|
Malaysia | Hospital University Sains Malaysia | Kubang Kerian | Kelantan |
Malaysia | Sarawak General Hospital | Kuching | Sarawak |
Lead Sponsor | Collaborator |
---|---|
Universiti Sains Malaysia |
Malaysia,
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* Note: There are 38 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subgaleal hematomas | Mean maximum thickness and volume of subgaleal hematomas as post craniectomy complication. Defined as maximum thickness and volume (using XYZ/2 formula) of subgaleal hematoma on CT brain post craniectomy. | 24 hours +/- 12 hours post craniectomy | |
Secondary | New remote hematomas | Rate of new remote hematomas. Defined as hematomas not previously seen on earlier CT brains but seen on post operative CT brain that cannot be explained by direct connection or complication from the original hematomas | 1 week post craniectomy | |
Secondary | Surgical site infection | Rate of surgical site infection. Defined as purulent or serous discharge from the surgical site with clinical signs of inflammation | 1 month post craniectomy | |
Secondary | Wound breakdown | Rate of wound breakdown. Defined as spontaneous separation of sutured edges | 1 month post craniectomy | |
Secondary | Bradycardia or hypotension during skin closure stage. | Rate of bradycardia or hypotension during skin closure stage. Bradycardia defined as <60 beat per minute, hypotension defined as BP <90/60 mmHg, that cannot be clearly explained by other possible causes | end of surgery till 30 minutes after surgery has ended | |
Secondary | Post craniectomy hydrocephalus | Rate of post craniectomy hydrocephalus. Defined as radiographic and clinical evidence of hydrocephalus post craniectomy | 6 months post craniectomy | |
Secondary | Functional outcome | Modified Rankin Scale(MRS) score on 6 months post craniectomy
MRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead. |
6 months post craniectomy |
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