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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-06-30

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.

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Detailed Description

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Conditions

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Pterional Craniotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control Group

Subjects who did not have a suction drain placed post-operatively following a Pterional Craniotomy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment Group

Subjects who did have a suction drain placed post-operatively following a Pterional Craniotomy at the location of surgical incision.

Group Type EXPERIMENTAL

Standard Suction Drain

Intervention Type PROCEDURE

The intervention of the experimental group will be a standard suction drain placed at the surgical site following a Pterional Craniotomy.

Interventions

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Standard Suction Drain

The intervention of the experimental group will be a standard suction drain placed at the surgical site following a Pterional Craniotomy.

Intervention Type PROCEDURE

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.)

Eligible Sex

ALL

Accepts Healthy Volunteers

No