Clinical trial NCT01867268: Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Fibrolipoma of Filum Terminale
Lipomyelomeningocele
Split Cord Malformation
Dermal Sinus
Tethered Cord Syndrome
Tumor
Keywords: Acetazolamide administration
prone positioning
Cerebrospinal fluid leakage
Cerebrospinal fluid collection
wound dehiscence
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-06-03
Enrollment: 144
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cerebrospinal fluid leakage
timeFrame: 1month
measure: Cerebrospinal fluid collection
timeFrame: 1 month
measure: wound dehiscence
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Children'S Medical Center
Study officials:
affiliation: Tehran University of Medical Sciences
name: Farideh Nejat, MD
role: STUDY_DIRECTOR
References:
citation: Chern JJ, Tubbs RS, Patel AJ, Gordon AS, Bandt SK, Smyth MD, Jea A, Oakes WJ. Preventing cerebrospinal fluid leak following transection of a tight filum terminale. J Neurosurg Pediatr. 2011 Jul;8(1):35-8. doi: 10.3171/2011.4.PEDS10502.
citation: Shahjouei S, Hanaei S, Habibi Z, Hoseini M, Ansari S, Nejat F. Randomized clinical trial of acetazolamide administration and/or prone positioning in mitigating wound complications following untethering surgeries. J Neurosurg Pediatr. 2016 Jun;17(6):659-66. doi: 10.3171/2015.8.PEDS15393. Epub 2016 Jan 29.