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Trials / Not Yet Recruiting

Not Yet RecruitingNCT06405698

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
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
2 Days – 1 Year
Healthy volunteers
Not accepted

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.

Conditions

Interventions

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

Timeline

Start date
2024-05-01
Primary completion
2025-11-01
Completion
2026-05-01
First posted
2024-05-08
Last updated
2024-05-08

Source: ClinicalTrials.gov record NCT06405698. Inclusion in this directory is not an endorsement.