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

University of Arizona

Status: Unknown

Conditions: Pterional Craniotomy

Treatments: Procedure: Standard Suction Drain

Study type: Interventional

Funder types: Other

Identifiers

NCT02792361

SCT1121

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Control Group

No Intervention group

Description:

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

Treatment Group

Experimental group

Description:

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

Treatment:

Procedure: Standard Suction Drain