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Comparison of Primary versus Rotational Flap Closure in Open Neural tube Defects

??A Randomised Control Study comparing Primary versus Rotational Flap Closure in Pediatric Open Neural Tube Defect Closure - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067931
Enrollment
88
Registered
2024-05-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: Q059- Spina bifida, unspecified

Interventions

Intervention1: Rotational Flap Closure: The measurement of skin defect size will be done on OT table after dural closure. Those with defect size more than 5cm will be randomised into two groups for ei

Sponsors

Dr Shubhalaxmi Nayak
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Infants under 3 months of age Diagnosis of open neural tube defect of defect size greater than 5cm longest diameter of skin defect which is measured after dural closure on the OT table Consent from parents or legal guardians obtained

Exclusion criteria

Exclusion criteria: Patients with ONTDs of over 3 months of age Patients with closed neural tube defects Lack of parental or legal guardian consent

Design outcomes

Primary

MeasureTime frame
Rates of dehiscence, infection, cerebrospinal fluid leakage, operative duration, the need for a second surgery, length of hospital stayTimepoint: Assessment at baseline after surgery and at follow up after 1 month, 6 months

Secondary

MeasureTime frame
Rates of dehiscence, infection, cerebrospinal fluid leakage, operative duration, the need for a second surgery, length of hospital stayTimepoint: by 1 year of follow up

Countries

India

Contacts

Public ContactDr Shubhalaxmi Nayak

Department of Pediatric Surgery, AIIMS Jodhpur

drshubhanyk@gmail.com9742022426

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026