NCT01867268

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

Evaluating the Effect of Acetazolamide Administration and Prone Positioning Following Lumbosacral Spinal Surgery in Preventing Cerebro Spinal Fluid Leakage and Collection and Wound Dehiscence in Children.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Acetazolamide	Acetazolamide administration for 10 days adjust dosage with weight of the patient
OTHER	prone positioning	prone positioning the patient for 10 days following the surgery
OTHER	Acetazolamide+ prone positioning	administration of acetazolamide and position the patient for 10 days following the surgery

Timeline

• Start date: 2012-10-01
• Primary completion: 2015-04-01
• Completion: 2015-09-01
• First posted: 2013-06-03
• Last updated: 2015-04-21

Locations

1 site across 1 country: Iran