Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405698
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-04-29
Brief Title:
Role of Perforator Flaps in Back Defects Reconstruction
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
A Randomized Comparison Between Perforator Flap vs Perforator Plus Flap in Myelomeningocele Defect Repair
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 21000 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 perforatorsLAP 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
The aetiology is multifactorial causes are genetic properties geographic factors and deficiency of folic acid
Meningomyelocele incidence range between 1 and 21000 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 perforatorsLAP 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None