Trial record 7 of 292 for:    Central Cord Syndrome

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Tehran University of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01867268
First received: May 29, 2013
Last updated: May 31, 2013
Last verified: May 2013
  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 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+ prone positioning for 10 days
    • Group D: no intervention
  • Period of study: Autumn 2012 to the end of winter of 2014

Condition Intervention Phase
Tethered Cord Syndrome
Split Cord Malformation
Lipoma of Spinal Cord
Drug: Acetazolamide
Other: prone positioning
Other: Acetazolamide+ prone positioning
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    leakage of CSF during 1 months following surgery

  • Cerebrospinal fluid collection [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    collection of the CSF beneath the skin during 1 month following the surgery

  • wound dehiscence [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    dehiscence of the surgical wound during the first month following surgery


Estimated Enrollment: 144
Study Start Date: October 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (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 adminestration and prone positioning following lumbosacral spinal surgery in preventing cerebro spinal fluid leakage and collection and wound dehissence in children admited to Children Medical Center of Tehran since Autumn 2012 to the end of winter of 2014.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+ 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+ prone positioning and the patient is considered as the failure of the protocol.
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • dethetering surgery
  • resection of lipoma
  • split cord malformation management
  • having any other disease with similar management technique

Exclusion Criteria:

  • myelomeningocele
  • lipomyelomeningocele
  • meningocele
  • occupying masses in spine such as

    • dermoid cysts
    • norenteric cysts
  • those who underwern reoperation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01867268     History of Changes
Other Study ID Numbers: 2137, 21843
Study First Received: May 29, 2013
Last Updated: May 31, 2013
Health Authority: Iran: Ethics Committee

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

Additional relevant MeSH terms:
Spinal Cord Neoplasms
Central Nervous System Diseases
Central Nervous System Neoplasms
Spinal Cord Diseases
Central Nervous System Agents
Congenital Abnormalities
Cerebrospinal Fluid Rhinorrhea
Intracranial Hypotension
Lipoma
Neural Tube Defects
Neurologic Manifestations
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Signs and Symptoms
Wounds and Injuries
Brain Diseases
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Nervous System Malformations
Nervous System Neoplasms
Neoplasms by Site
Acetazolamide
Anticonvulsants
Therapeutic Uses
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014