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

Study Overview
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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

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.

Official Title
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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.

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

Intervention / Treatment
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* Drug: Acetazolamide
* Other: prone positioning
* Other: Acetazolamide+ prone positioning


Participation Criteria
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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 Exclusion Criteria: Infected dermoid tumors Intramedullary abscess Myelomeningocele surgery and related reoperation Meningocele Presence of hydrocephalus

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acetazolamide<br>administration of Acetazolamide for 10 days following the surgery | Drug: Acetazolamide<br>* Acetazolamide administration for 10 days adjust dosage with weight of the patient<br>* Other names: Diamox;|
| No Intervention: Control<br>control group without any intervention | |
| Experimental: Prone positioning<br>Positioning the patient following surgery for 10 days | Other: prone positioning<br>* prone positioning the patient for 10 days following the surgery<br>|
| Experimental: Acetazolamide and Prone positioning<br>applying both Acetazolamide and prone positioning | Other: Acetazolamide+ prone positioning<br>* administration of acetazolamide and position the patient for 10 days following the surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebrospinal fluid leakage | leakage of CSF during 1 months following surgery | 1month | 
| Cerebrospinal fluid collection | collection of the CSF beneath the skin during 1 month following the surgery | 1 month | 
| wound dehiscence | dehiscence of the surgical wound during the first month following surgery | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebrospinal fluid leakage, Cerebrospinal fluid collection, wound dehiscence, Acetazolamide administration, prone positioning