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

Sponsor

Tehran University of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT01867268

Collaborator

(none)

144

Enrollment

Location

Arms

Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	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

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 Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

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.

Study Start Date :

Oct 1, 2012

Anticipated Primary Completion Date :

Apr 1, 2015

Anticipated Study Completion Date :

Sep 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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