Role of Perforator Flaps in Back Defects Reconstruction

NCT ID: NCT06405698

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-31

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

evaluation of perforator flaps versus perforator plus flaps

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Myelomeningocele

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

closure of the myelomeningocele defect by perforator flap.

fifteen patient with myelomeningocele defect

Group Type EXPERIMENTAL

surgical closure of myelomeningocele defects by perforator flaps

Intervention Type PROCEDURE

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

closure of the myelomeningocele defect by perforator plus flap .

fifteen patient with myelomeningocele defect

Group Type EXPERIMENTAL

surgical closure of myelomeningocele defects by perforator-plus flaps

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 .

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

2 Days

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed elsayed tawfik

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

mahmoud Abdelaal, doctor

Role: STUDY_DIRECTOR

professor

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

mohamed tawfik, doctor

Role: CONTACT

01029980167

Osama taha, professor

Role: CONTACT

01069468684

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21301309 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24918736 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26010351 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32110822 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

flaps in myelomeningiocele

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Percutaneous Trans-facet Spine Fixation
NCT07001969 ENROLLING_BY_INVITATION NA