Role of Perforator Flaps in Back Defects Reconstruction

Myelomeningocele Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06405698
• Other study ID #: flaps in myelomeningiocele
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2026

Study information

• Verified date: May 2024
• Source: Assiut University
• Contact: mohamed tawfik, doctor
• Phone: 01029980167
• Email: mtawfik206[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

evaluation of perforator flaps versus perforator plus flaps

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 2026
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Days to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Meningomyelocele
• Myelomeningocele

Intervention

Procedure:
• surgical 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 .
• surgical 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changing complication rate	evaluate of different flaps modalities in back defects closure	baseline and 3 months
Primary	changing hospital stay time		baseline and one month