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CompletedNCT05188300Updated Jan 12, 2022

Propellers Flaps for Meningomylocele Defects

An interventional study of Freestyle pedicled perforators propellers flaps for meningomyelocele defects in Meningocele and Meningomyelocele, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 1 Day to 6 Months. Per ClinicalTrials.gov, last updated 2022-01-12.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 11 months after the study started (first participant enrolled Jan 2019, registered Dec 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
1 Day to 6 Months
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Meningocele
  • Meningomyelocele

Keywords

  • Reconstructive Surgical Procedures / adverse effects
  • Meningomyelocele / surgery
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In context

Meningomyelocele

56 studies on the registry are indexed under Meningomyelocele; 14 are open to participants now.

This study's enrollment of 40 is above the median of 35 across 39 interventional studies indexed under Meningomyelocele.

Browse Meningomyelocele studies →

Lead sponsor

Assiut University is the lead sponsor of 4,916 studies on the registry; 2,113 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Day to 6 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Dorsal intercostal artery (DICA) perforator flaps

    Retrograde dissection of free style perforator arising from DICA according to region of dorsal spine and identification of paraspinal muscle where perforator vessel was found

    Procedure: Freestyle pedicled perforators propellers flaps for meningomyelocele defects

  • Experimental
    Trapezius musculocutaneous perforator flaps

    Retrograde dissection of a free style perforator arising as a trapezius myocutenous perforator where the trapezius muscle is identified and a perforator vessel was isolated.

    Procedure: Freestyle pedicled perforators propellers flaps for meningomyelocele defects

  • Experimental
    Lumbar artery perforators flaps

    Retrograde dissection of free style perforator arising from lumbar artery according to region of lumbar spine and identification of lumbar fascia where perforator vessel was found

    Procedure: Freestyle pedicled perforators propellers flaps for meningomyelocele defects

Interventions

  • ProcedureFreestyle pedicled perforators propellers flaps for meningomyelocele defects

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

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What researchers measure

Primary outcomes

  1. Feasibility of reconstruction technique

    Measure the average operative time in minutes in each arm.

    Time frame: Time of procedure

  2. Pedicle dissection beyond the muscle

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

    Time frame: Time of procedure

Secondary outcomes

  1. Meningomyelocele Repair Dehiscence and/or CSF leak

    Compare the number of each complication in each arm

    Time frame: Time of procedure

07

Study locations

1 site
  • Mohamed Abdeltawab
    Assiut, 71515, Egypt
08

References and documents

Publications

  • Kushida-Contreras BH, Gaxiola-Garcia MA. Myelomeningocele defect reconstruction with keystone flaps: vascular rationale for the design and operative technique. Arch Plast Surg. 2021 May;48(3):254-260. doi: 10.5999/aps.2020.01746. Epub 2021 May 15. PubMed 34024069 ↗
  • Formentin C, de Andrade EJ, Matias LG, Joaquim AF, Tedeschi H, Raposo-Amaral CE, Ghizoni E. Using the keystone design perforator island flap in large myelomeningocele closure. Neurosurg Focus. 2019 Oct 1;47(4):E19. doi: 10.3171/2019.7.FOCUS19383. PubMed 31574473 ↗
  • Kesan K, Kothari P, Gupta R, Gupta A, Karkera P, Ranjan R, Mutkhedkar K, Sandlas G. Closure of large meningomyelocele wound defects with subcutaneous based pedicle flap with bilateral V-Y advancement: our experience and review of literature. Eur J Pediatr Surg. 2015 Apr;25(2):189-94. doi: 10.1055/s-0034-1368796. Epub 2014 Mar 28. PubMed 24683103 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05188300
Lead sponsor
Assiut University
Responsible party
Mohamed Abdel-Tawab Mohamed (Lecturer, Assiut University) — Principal investigator
First posted
Jan 12, 2022
Start date
Jan 1, 2019
Primary completion
Oct 1, 2021
Completion
Nov 1, 2021
Last update
Jan 12, 2022

Study contacts

Mohamed K Kamel
principal investigator · Assiut University
Awni M Shawkat, MD
study chair · Assiut University
Mahmoud A Mohamed
study director · Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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