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

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.

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01867268
Enrollment
144
Registered
2013-06-03
Start date
2012-10-31
Completion date
2015-09-30
Last updated
2015-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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

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.

Interventions

OTHERAcetazolamide+ prone positioning

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

DRUGAcetazolamide

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

OTHERprone positioning

prone positioning the patient for 10 days following the surgery

Sponsors

Tehran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cerebrospinal fluid leakage1monthleakage of CSF during 1 months following surgery
Cerebrospinal fluid collection1 monthcollection of the CSF beneath the skin during 1 month following the surgery
wound dehiscence1 monthdehiscence of the surgical wound during the first month following surgery

Countries

Iran

Contacts

Primary ContactFarideh Nejat, MD
nejat@tums.ac.ir+98 912 1494064

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026