NCT05188300

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
Last Updated

January 12, 2022

Status Verified

December 1, 2021

Enrollment Period

2.8 years

First QC Date

December 26, 2021

Last Update Submit

December 26, 2021

Conditions

MeningoceleMeningomyelocele

Keywords

Reconstructive Surgical Procedures / adverse effectsMeningomyelocele / surgery

Outcome Measures

Primary Outcomes (2)

  • Feasibility of reconstruction technique

    Measure the average operative time in minutes in each arm.

    Time of procedure

  • Pedicle dissection beyond the muscle

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

    Time of procedure

Secondary Outcomes (1)

  • Meningomyelocele Repair Dehiscence and/or CSF leak

    Time of procedure

Study Arms (3)

Dorsal intercostal artery (DICA) perforator flaps

EXPERIMENTAL

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

Trapezius musculocutaneous perforator flaps

EXPERIMENTAL

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

Lumbar artery perforators flaps

EXPERIMENTAL

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

Freestyle pedicled perforators propellers flaps for meningomyelocele defectsPROCEDURE

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

Dorsal intercostal artery (DICA) perforator flapsLumbar artery perforators flapsTrapezius musculocutaneous perforator flaps

Eligibility Criteria

Age1 Day - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Abdeltawab

Asyut, 71515, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 34024069BACKGROUND

  • 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.

    PMID: 31574473BACKGROUND

  • 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.

    PMID: 24683103BACKGROUND

MeSH Terms

Conditions

MeningoceleMeningomyelocele

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Mohamed K Kamel

    Assiut University

    PRINCIPAL INVESTIGATOR

  • Awni M Shawkat, MD

    Assiut University

    STUDY CHAIR

  • Mahmoud A Mohamed

    Assiut University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 26, 2021

First Posted

January 12, 2022

Study Start

January 1, 2019

Primary Completion

October 1, 2021

Study Completion

November 1, 2021

Last Updated

January 12, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)