NCT02792361

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pterional Craniotomy

Interventions

Type	Name	Description
PROCEDURE	Standard Suction Drain	The intervention of the experimental group will be a standard suction drain placed at the surgical site following a Pterional Craniotomy.

Timeline

• Start date: 2016-06-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2016-06-07
• Last updated: 2016-06-07