Role of Perforator Flaps in Back Defects Reconstruction

May 6, 2024 updated by: Mohamed elsayed tawfik, Assiut University

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

evaluation of perforator flaps versus perforator plus flaps

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: closure of the myelomeningocele defect by perforator flap.
fifteen patient with myelomeningocele defect
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 .
Experimental: closure of the myelomeningocele defect by perforator plus flap .
fifteen patient with myelomeningocele defect
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changing complication rate
Time Frame: baseline and 3 months
evaluate of different flaps modalities in back defects closure
baseline and 3 months
changing hospital stay time
Time Frame: baseline and one month
baseline and one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: mahmoud Abdelaal, doctor, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • flaps in myelomeningiocele

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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