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

April 17, 2015 updated by: Tehran University of Medical Sciences

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.

  • 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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Recruiting
        • Children's Medical Center
        • Contact:
          • Phone Number: +98 21 61479
        • Principal Investigator:
          • Shima Shahjouei, Student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebrospinal fluid leakage
Time Frame: 1month
leakage of CSF during 1 months following surgery
1month
Cerebrospinal fluid collection
Time Frame: 1 month
collection of the CSF beneath the skin during 1 month following the surgery
1 month
wound dehiscence
Time Frame: 1 month
dehiscence of the surgical wound during the first month following surgery
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Study Director: Farideh Nejat, MD, Tehran University Of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

May 31, 2013

First Posted (Estimate)

June 3, 2013

Study Record Updates

Last Update Posted (Estimate)

April 21, 2015

Last Update Submitted That Met QC Criteria

April 17, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2137
  • 21843 (Other Identifier: Tehran University of Medical Sciences)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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