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Clinical Trial Summary

- 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


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01867268
Study type Interventional
Source Tehran University of Medical Sciences
Contact Farideh Nejat, MD
Phone +98 912 1494064
Email nejat@tums.ac.ir
Status Recruiting
Phase Phase 2
Start date October 2012
Completion date September 2015

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