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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01867268
First Posted: June 3, 2013
Last Update Posted: April 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tehran University of Medical Sciences
  Purpose
  • 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

Condition Intervention Phase
Fibrolipoma of Filum Terminale Lipomyelomeningocele Split Cord Malformation Dermal Sinus Tethered Cord Syndrome Tumor Drug: Acetazolamide Other: prone positioning Other: Acetazolamide+ prone positioning Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 144
Study Start Date: October 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acetazolamide
administration of Acetazolamide for 10 days following the surgery
Drug: Acetazolamide
Acetazolamide administration for 10 days adjust dosage with weight of the patient
Other Name: Diamox
No Intervention: Control
control group without any intervention
Experimental: Prone positioning
Positioning the patient following surgery for 10 days
Other: prone positioning
prone positioning the patient for 10 days following the surgery
Experimental: Acetazolamide and Prone positioning
applying both Acetazolamide and prone positioning
Other: Acetazolamide+ prone positioning
administration of acetazolamide and position the patient for 10 days following the surgery

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867268


Contacts
Contact: Farideh Nejat, MD +98 912 1494064 nejat@tums.ac.ir

Locations
Iran, Islamic Republic of
Children`S Medical Center Recruiting
Tehran, Iran, Islamic Republic of
Contact    +98 21 61479      
Principal Investigator: Shima Shahjouei, Student         
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Study Director: Farideh Nejat, MD Tehran University of Medical Sciences
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01867268     History of Changes
Other Study ID Numbers: 2137
21843 ( Other Identifier: Tehran University of Medical Sciences )
First Submitted: May 29, 2013
First Posted: June 3, 2013
Last Update Posted: April 21, 2015
Last Verified: April 2015

Keywords provided by Tehran University of Medical Sciences:
Acetazolamide administration
prone positioning
Cerebrospinal fluid leakage
Cerebrospinal fluid collection
wound dehiscence

Additional relevant MeSH terms:
Congenital Abnormalities
Neural Tube Defects
Spina Bifida Occulta
Nervous System Malformations
Nervous System Diseases
Spinal Dysraphism
Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs