Clinical trial NCT06405698: Role of Perforator Flaps in Back Defects Reconstruction
Official title: A Randomized Comparison Between Perforator Flap vs Perforator Plus Flap in Myelomeningocele Defect Repair
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Myelomeningocele
Keywords: myelomeningocele
perforator flaps
infants
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: changing complication rate
timeFrame: baseline and 3 months
measure: changing hospital stay time
timeFrame: baseline and one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: professor
name: mahmoud Abdelaal, doctor
role: STUDY_DIRECTOR
References:
citation: Isik D, Tekes L, Eseoglu M, Isik Y, Bilici S, Atik B. Closure of large myelomeningocele defects using dorsal intercostal artery perforator flap. Ann Plast Surg. 2011 Aug;67(2):159-63. doi: 10.1097/SAP.0b013e3181f3e0cf.
citation: Cologlu H, Ozkan B, Uysal AC, Cologlu O, Borman H. Bilateral propeller flap closure of large meningomyelocele defects. Ann Plast Surg. 2014 Jul;73(1):68-73. doi: 10.1097/SAP.0b013e31826caf5a.
citation: Basterzi Y, Tenekeci G. Dorsal Intercostal Artery Perforator Propeller Flaps: A Reliable Option in Reconstruction of Large Meningomyelocele Defects. Ann Plast Surg. 2016 Apr;76(4):434-7. doi: 10.1097/SAP.0000000000000417.
citation: Kehrer A, Heidekrueger PI, Lonic D, Taeger CD, Klein S, Lamby P, Sachanadani NS, Jung EM, Prantl L, Batista da Silva NP. High-Resolution Ultrasound-Guided Perforator Mapping and Characterization by the Microsurgeon in Lower Limb Reconstruction. J Reconstr Microsurg. 2021 Jan;37(1):75-82. doi: 10.1055/s-0040-1702162. Epub 2020 Feb 28.