A Clinical Effectiveness Trial in Post-Operative Pterional Craniotomy Drain Placement

Study Overview
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Brief Summary
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This is a clinical trial where patients who present to the neurosurgery service in need of a procedure that requires a pterional craniotomy will be screened, and if eligible, enrolled for the randomization in the placement of a drain at the surgical site. At present, there is not a protocol for whether or not to use a drain following this procedure. There is some debate on whether it serves any real benefit for the patient or if it may actually be detrimental in cases where infection occurs. This study aims to answer this question by randomizing patients to drain placement and then comparing patient outcomes between the two groups. These include the following: infection rate, length of hospital stay, self-reported patient pain and discomfort, the amount of time before patients are able to open their eye ipsilateral to the side of operation, change in forehead circumference post-op days 1-3, and any unforeseen post-operative complications. This will be accomplished through using a patient-administered survey, recording physical measurements, and a patient chart review. Statistical analysis will then be used to identify any differences that may exist.

Official Title
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A Randomized, Non-Blind, Clinical Effectiveness Trial in Post-Operative Pterional Craniotomy Drain Placement

Conditions
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Pterional Craniotomy

Intervention / Treatment
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* Procedure: Standard Suction Drain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients that have been scheduled for surgery requiring the use of a pterional craniotomy approach Exclusion Criteria: Patients in need of a surgical intervention requiring a pterional craniotomy due to reasons of physical injury Patients who need a pterional craniotomy with a orbitozygomatic approach Patients who have noticeable physical injury to their skull Patients with a prior surgical history of a craniotomy Patients with a pathological condition deemed severe enough by the screening physician to possibly influence the healing process of the procedure (blood clot disorder, cirrhosis, severe nutrient depletion, congestive heart failure etc.)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Subjects who did not have a suction drain placed post-operatively following a Pterional Craniotomy. | |
| Experimental: Treatment Group<br>Subjects who did have a suction drain placed post-operatively following a Pterional Craniotomy at the location of surgical incision. | Procedure: Standard Suction Drain<br>* The intervention of the experimental group will be a standard suction drain placed at the surgical site following a Pterional Craniotomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Length of Hospital Stay | Compare the length of hospital between the treatment groups and determine whether a significant difference exists. | From the date of surgery to the date of discharge from the hospital for up to 16 weeks following surgery, or until death, depending which comes first. | 
| Head Circumference Difference | Compare the change in measured forehead circumference between treatment groups on post-operative days 1-3. Determine if a significant difference exists between the two. | Day 1 through Day 3 following surgery. | 
| Pain Difference | Compare the reported pain/ discomfort between the patients who had drain placement from those who did not. This will be performed using a survey administered to patients upon removal of the drain | At the time of discharge from the hospital but no longer than up to 16 weeks from the date of surgery. | 
| Ability to open ipsilateral eye to surgical site. | Compare the number of subjects able to open and close their eye on the ipsilateral side of the surgical site between the study groups | Day 1 through Day 3 following surgery. | 
| Complication Rate | An overall assessment comparing complications between the two study groups will be performed. This will include looking things such as hospital acquired pneumonia, the development of any new neurological conditions or deficiencies, and other unforeseen complications that may arise which are not be directly related to the drain but may potentially still be influenced by it. | From the date of surgery to the date of discharge from the hospital for up to 16 weeks following surgery, or until death, depending which comes first. | 
| Surgical site infection rate | Compare infections rates between patients with drains placement versus those who did not. Determine if there is any statistically significant difference in risk exists between the two study populations. | From the date of surgery to the date of discharge from the hospital for up to 16 weeks following surgery, or until death, depending which comes first. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-Operative Pterional Craniotomy, Suction Drain, Benefits