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

Tehran University of Medical Sciences

Status and phase: Unknown; Phase 2

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

Treatments: Other: Acetazolamide+ prone positioning; Drug: Acetazolamide; Other: prone positioning

Study type: Interventional

Funder types: Other

Identifiers

NCT01867268

21843 (Other Identifier)

2137

Details and patient eligibility

About

• 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

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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144 participants in 4 patient groups

Acetazolamide

Experimental group

Description:

administration of Acetazolamide for 10 days following the surgery

Treatment:

Drug: Acetazolamide

Control

No Intervention group

Description:

control group without any intervention

Prone positioning

Experimental group

Description:

Positioning the patient following surgery for 10 days

Treatment:

Other: prone positioning

Acetazolamide and Prone positioning

Experimental group

Description:

applying both Acetazolamide and prone positioning

Treatment:

Other: Acetazolamide+ prone positioning