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Role of Perforator Flaps in Back Defects Reconstruction

A Randomized Comparison Between Perforator Flap vs Perforator Plus Flap in Myelomeningocele Defect Repair

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06405698
Enrollment
30
Registered
2024-05-08
Start date
2024-05-31
Completion date
2026-05-31
Last updated
2024-05-08

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

Conditions

Myelomeningocele

Keywords

myelomeningocele, perforator flaps, infants

Brief summary

evaluation of perforator flaps versus perforator plus flaps

Detailed description

One of the neural tube defects, myelomeningocele, is a congenital anomaly developing in the fourth gestational week. It is characterized by insertion of neural elements into a pouch floored by meninx through a vertebral defect. The aetiology is multifactorial. causes are genetic properties, geographic factors, and deficiency of folic acid. Meningomyelocele incidence range between 1 and 2/1000 live births. The defect location can reside anywhere between the cervical region and the sacrum. surgical closure of the defect is performed to prevent cerebrospinal fluid leakage and central nervous system infections. it is a combined work between neurosurgery and plastic surgery. Fascial turnover flaps, muscle flaps, local fasciocutaneous flaps. With the emerging concepts of perforator flaps in the last three decades, the reconstruction of myelomeningocele defects has completely changed since the anatomy of the dorsal intercostal artery perforators (DIAP) and lumbar artery perforators(LAP) has been fully studied. Despite utilizing perforator flaps having greatly improved the outcome of myelomeningocele reconstruction, venous compromise remained a major concern associated with complications. By preserving, the perforator vessels and minimizing the amount of tissue that is removed, the Perforator Plus technique can improve blood flow and decrease the risk of venous congestion. Preoperative perforator mapping may be executed by a multitude of diagnostic modalities. Hand-held Doppler (HHD), color-coded duplex sonography (CCDS), computed tomography angiography (CTA), magnetic resonance angiography (MRA) and others may be applied. Systematic reviews of the literature revealed that CCDS has the highest sensitivity and positive predictive value to identify perforators for flaps.

Interventions

PROCEDUREsurgical closure of myelomeningocele defects by perforator flaps

closure of myelomeningocele defect by perforator island flap after complete incision of the flap all around based on perforator vessel .

PROCEDUREsurgical closure of myelomeningocele defects by perforator-plus flaps

closure of myelomeningocele defect by perforator-plus island flap harvesting leaving skin bridge connecting to the flap and dissection of the perforator vessel

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
2 Days to 1 Years
Healthy volunteers
No

Inclusion criteria

* infants up to one year, * dorso-lumbar myelomeningocele. * moderate to large myelomeningocele defects. (25 - 39 cm2 ) .

Exclusion criteria

* cervical myelomeningocele * very large defects (more than 40 cm2 ) * preterm newborn patients. * hematological disease * any problem against prone position of the patient

Design outcomes

Primary

MeasureTime frameDescription
changing complication ratebaseline and 3 monthsevaluate of different flaps modalities in back defects closure
changing hospital stay timebaseline and one month

Contacts

Primary Contactmohamed tawfik, doctor
mtawfik206@aun.edu.eg01029980167
Backup ContactOsama taha, professor
osamataha@osamataha.health01069468684

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026