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Completed

NCT Number: NCT05188300

Propellers Flaps for Meningomylocele Defects

To evaluate reliability of free style propeller perforator flap for coverage MMC soft tissue defect follow a well-established step that overcome the usual problem of pedicled perforators propellers flaps.

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Key information

Conditions

Meningocele Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Meningomyelocele Nervous System Diseases Nervous System Malformations Neural Tube Defects Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

1 day–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohamed Abdeltawab

Asyut, 71515, Egypt

About this study

Meningomyelocele is a serious congenital birth defect that not only affect mortality and morbidity of neonate but also a lifelong health problem.

The estimated incidence of spina bifida is 1-2 cases per 1000 population. Meningomylocele soft tissue defect reconstruction is considered a lifesaving procedure , the ideal coverage technique should be time limited , reliable and allow healing line to be away from repair of the dura . all of these criteria are available in the selection of free style propeller perforator flap as a method of reconstruction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All cases with dorsolumbar meningomyelocele and age up to 6 months

Exclusion criteria

  • Infants older than 6 months
  • concomitant congenital anomalies
  • concomitant spinal kyphosis

Treatment and study plan

Freestyle pedicled perforators propellers flaps for meningomyelocele defects

Procedure

Freestyle pedicled perforators propellers flaps for meningomyelocele defects reconstruction with sequential advance in perforators dissection, large number cases, and detailed successful technique.

Primary outcomes

  1. Feasibility of reconstruction technique

    Time frame: Time of procedure

    Measure the average operative time in minutes in each arm.

  2. Pedicle dissection beyond the muscle

    Time frame: Time of procedure

    Compare the number of pedicle dissection beyond the muscle in each group.

Secondary outcomes

  1. Meningomyelocele Repair Dehiscence and/or CSF leak

    Time frame: Time of procedure

    Compare the number of each complication in each arm

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Free Style Pedicled Perforators Propellers Flaps for Meningomylocele Defects Reconstruction With Sequential Advance in Perforators Dissection

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 12, 2022
Registry last updated
Jan 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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