Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence

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

PHASE2

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-09-30

Brief Summary

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* Purpose of study : to determine the preventive effect of acetazolamide administration, prone positioning, and the combination of both following the neurosurgical interventions in lumbosacral region for cerebrospinal fluid (CSF) leak, CSF collection and wound dehiscence.
* Sample size: 144
* intervention groups:

* Group A: Acetazolamide administration for 10 days
* Group B: prone positioning for 10 days
* Group C: Acetazolamide administration and prone positioning for 10 days
* Group D: no intervention
* Period of study: Autumn 2012 to the end of winter of 2015

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Detailed Description

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The purpose of this study is to evaluate the effect of Acetazolamide administration and prone positioning following lumbosacral spinal surgery in preventing cerebro-spinal fluid leakage and collection and wound dehissence in children admitted to Children Medical Center of Tehran since Autumn 2012 to the end of winter of 2015.The study is run under 4 categories of intervention:

* Group A: Acetazolamide administration for 10 days
* Group B: prone positioning for 10 days
* Group C: Acetazolamide administration and prone positioning for 10 days
* Group D: no intervention All patients are randomly assigned to these groups and when the patients faced with any of these complications, the protocol changes to Acetazolamide administration and prone positioning and the patient is considered as the failure of the protocol.

Conditions

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Fibrolipoma of Filum Terminale Lipomyelomeningocele Split Cord Malformation Dermal Sinus Tethered Cord Syndrome Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Acetazolamide

administration of Acetazolamide for 10 days following the surgery

Group Type EXPERIMENTAL

Acetazolamide

Intervention Type DRUG

Acetazolamide administration for 10 days adjust dosage with weight of the patient

Control

control group without any intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Prone positioning

Positioning the patient following surgery for 10 days

Group Type EXPERIMENTAL

prone positioning

Intervention Type OTHER

prone positioning the patient for 10 days following the surgery

Acetazolamide and Prone positioning

applying both Acetazolamide and prone positioning

Group Type EXPERIMENTAL

Acetazolamide+ prone positioning

Intervention Type OTHER

administration of acetazolamide and position the patient for 10 days following the surgery

Interventions

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Acetazolamide

Acetazolamide administration for 10 days adjust dosage with weight of the patient

Intervention Type DRUG

prone positioning

prone positioning the patient for 10 days following the surgery

Intervention Type OTHER

Acetazolamide+ prone positioning

administration of acetazolamide and position the patient for 10 days following the surgery

Intervention Type OTHER

Other Intervention Names

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Diamox

Eligibility Criteria

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Inclusion Criteria

* Untethering surgery for primary tethered cord caused by thick filum
* Lipomyelomeningocele
* Split cord malformation management
* Untethering surgery in uncomplicated Dermal sinus
* Tumors needing intradural management in lumbosacral region
* Having any other disease with similar management technique