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

NCT01867268 | Unknown Phase 2 DMC

• 2 other identifiers: 213721843
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Acetazolamide administration; prone positioning; Cerebrospinal fluid leakage; Cerebrospinal fluid collection; wound dehiscence

Outcome Measures

Primary Outcomes (3)

• Cerebrospinal fluid leakage

  leakage of CSF during 1 months following surgery

  1month

• Cerebrospinal fluid collection

  collection of the CSF beneath the skin during 1 month following the surgery

  1 month

• wound dehiscence

  dehiscence of the surgical wound during the first month following surgery

  1 month

Study Arms (4)

Acetazolamide

EXPERIMENTAL

administration of Acetazolamide for 10 days following the surgery

Drug: Acetazolamide

Control

NO INTERVENTION

control group without any intervention

Prone positioning

EXPERIMENTAL

Positioning the patient following surgery for 10 days

Other: prone positioning

Acetazolamide and Prone positioning

EXPERIMENTAL

applying both Acetazolamide and prone positioning

Other: Acetazolamide+ prone positioning

Interventions

Acetazolamide DRUG

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

Also known as: Diamox

Acetazolamide

prone positioning OTHER

prone positioning the patient for 10 days following the surgery

Prone positioning

Acetazolamide+ prone positioning OTHER

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

Acetazolamide and Prone positioning

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Infected dermoid tumors
• Intramedullary abscess
• Myelomeningocele surgery and related reoperation
• Meningocele
• Presence of hydrocephalus

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Children'S Medical Center

Tehran, Tehran Province, Iran

RECRUITING

Related Publications (2)

• 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.

  PMID: 21721886 BACKGROUND

• Shahjouei S, Hanaei S, Habibi Z, Hoseini M, Ansari S, Nejat F. Randomized clinical trial of acetazolamide administration and/or prone positioning in mitigating wound complications following untethering surgeries. J Neurosurg Pediatr. 2016 Jun;17(6):659-66. doi: 10.3171/2015.8.PEDS15393. Epub 2016 Jan 29.

  PMID: 26824595 DERIVED

MeSH Terms

Conditions

Lipomyelomeningocele; Neural Tube Defects; Spina Bifida Occulta; Neoplasms; Cerebrospinal Fluid Leak

Interventions

Acetazolamide; Prone Position

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Spinal Dysraphism; Neurologic Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Farideh Nejat, MD

  Tehran University of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Farideh Nejat, MD

CONTACT

+98 912 1494064; nejat@tums.ac.ir

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 3, 2013
• Study Start: October 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 21, 2015

Record last verified: 2015-04

Locations

IR (1)