DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Tehran University of Medical Sciences
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fibrolipoma of Filum Terminale; Lipomyelomeningocele; Split Cord Malformation; Dermal Sinus; Tethered Cord Syndrome; Tumor

Intervention: Acetazolamide (Drug); prone positioning (Other); Acetazolamide+ prone positioning (Other)

Phase: Phase 2

Status: Recruiting

Sponsored by: Tehran University of Medical Sciences

Official(s) and/or principal investigator(s):
Farideh Nejat, MD, Study Director, Affiliation: Tehran University of Medical Sciences

Overall contact:
Farideh Nejat, MD, Phone: +98 912 1494064, Email: nejat@tums.ac.ir

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Cerebrospinal fluid leakage

Cerebrospinal fluid collection

wound dehiscence

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

Minimum age: N/A. Maximum age: 18 Years. Gender(s): Both.

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

Locations and Contacts

Farideh Nejat, MD, Phone: +98 912 1494064, Email: nejat@tums.ac.ir

Children`S Medical Center, Tehran, Iran, Islamic Republic of; Recruiting
Phone: +98 21 61479
Shima Shahjouei, Student, Principal Investigator
Additional Information

Related publications:

Chern JJ, Tubbs RS, Patel AJ, Gordon AS, Bandt SK, Smyth MD, Jea A, Oakes WJ. Preventing cerebrospinal fluid leak following transection of a tight filum terminale. J Neurosurg Pediatr. 2011 Jul;8(1):35-8. doi: 10.3171/2011.4.PEDS10502.

Starting date: October 2012
Last updated: April 17, 2015

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017