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

Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Evaluating the Effect of Acetazolamide Administration and Prone Positioning Following Lumbosacral Spinal Surgery in Preventing Cerebro Spinal Fluid Leakage and Collection

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 Summary:

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.

Sponsor: Tehran University of Medical Sciences

Current Primary Outcome:

  • Cerebrospinal fluid leakage [ Time Frame: 1month ]
    leakage of CSF during 1 months following surgery
  • Cerebrospinal fluid collection [ Time Frame: 1 month ]
    collection of the CSF beneath the skin during 1 month following the surgery
  • wound dehiscence [ Time Frame: 1 month ]
    dehiscence of the surgical wound during the first month following surgery


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Tehran University of Medical Sciences

Dates:
Date Received: May 29, 2013
Date Started: October 2012
Date Completion: September 2015
Last Updated: April 17, 2015
Last Verified: April 2015