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

NCT01867268 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2015-04-21

No results posted yet for this study

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

Conditions

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

Interventions

DRUG

Acetazolamide

Acetazolamide administration for 10 days adjust dosage with weight of the patient

OTHER

prone positioning

prone positioning the patient for 10 days following the surgery

OTHER

Acetazolamide+ prone positioning

administration of acetazolamide and position the patient for 10 days following the surgery

Sponsors & Collaborators

  • Tehran University of Medical Sciences

    lead OTHER

Principal Investigators

  • Farideh Nejat, MD · Tehran University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-04-30
Completion
2015-09-30

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01867268 on ClinicalTrials.gov