Clinical trial NCT02792361: A Clinical Effectiveness Trial in Post-Operative Pterional Craniotomy Drain Placement
Official title: A Randomized, Non-Blind, Clinical Effectiveness Trial in Post-Operative Pterional Craniotomy Drain Placement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pterional Craniotomy
Keywords: Post-Operative Pterional Craniotomy
Suction Drain
Benefits
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2016-06-07
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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.)

Primary outcomes:
measure: Difference in Length of Hospital Stay
timeFrame: 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.
measure: Head Circumference Difference
timeFrame: Day 1 through Day 3 following surgery.
measure: Pain Difference
timeFrame: At the time of discharge from the hospital but no longer than up to 16 weeks from the date of surgery.
measure: Ability to open ipsilateral eye to surgical site.
timeFrame: Day 1 through Day 3 following surgery.
measure: Complication Rate
timeFrame: 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.
measure: Surgical site infection rate
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Chaddad-Neto F, Campos Filho JM, Doria-Netto HL, Faria MH, Ribas GC, Oliveira E. The pterional craniotomy: tips and tricks. Arq Neuropsiquiatr. 2012 Sep;70(9):727-32. doi: 10.1590/s0004-282x2012000900015.
citation: Dougherty SH, Simmons RL. The biology and practice of surgical drains. Part II. Curr Probl Surg. 1992 Sep;29(9):633-730. doi: 10.1016/0011-3840(92)90028-2. No abstract available.
citation: Cruse PJ, Foord R. A five-year prospective study of 23,649 surgical wounds. Arch Surg. 1973 Aug;107(2):206-10. doi: 10.1001/archsurg.1973.01350200078018. No abstract available.
citation: Mollman HD, Haines SJ. Risk factors for postoperative neurosurgical wound infection. A case-control study. J Neurosurg. 1986 Jun;64(6):902-6. doi: 10.3171/jns.1986.64.6.0902.