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Propellers Flaps for Meningomylocele Defects

Primary Purpose

Meningocele, Meningomyelocele

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Freestyle pedicled perforators propellers flaps for meningomyelocele defects
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meningocele focused on measuring Reconstructive Surgical Procedures / adverse effects, Meningomyelocele / surgery

Eligibility Criteria

1 Day - 6 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mohamed Abdeltawab

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Dorsal intercostal artery (DICA) perforator flaps

Trapezius musculocutaneous perforator flaps

Lumbar artery perforators flaps

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

Feasibility of reconstruction technique
Measure the average operative time in minutes in each arm.
Pedicle dissection beyond the muscle
Compare the number of pedicle dissection beyond the muscle in each group.

Secondary Outcome Measures

Meningomyelocele Repair Dehiscence and/or CSF leak
Compare the number of each complication in each arm

Full Information

First Posted
December 26, 2021
Last Updated
December 26, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05188300
Brief Title
Propellers Flaps for Meningomylocele Defects
Official Title
Free Style Pedicled Perforators Propellers Flaps for Meningomylocele Defects Reconstruction With Sequential Advance in Perforators Dissection
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningocele, Meningomyelocele
Keywords
Reconstructive Surgical Procedures / adverse effects, Meningomyelocele / surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dorsal intercostal artery (DICA) perforator flaps
Arm Type
Experimental
Arm Description
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
Arm Title
Trapezius musculocutaneous perforator flaps
Arm Type
Experimental
Arm Description
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.
Arm Title
Lumbar artery perforators flaps
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Freestyle pedicled perforators propellers flaps for meningomyelocele defects
Intervention Description
Freestyle pedicled perforators propellers flaps for meningomyelocele defects reconstruction with sequential advance in perforators dissection, large number cases, and detailed successful technique.
Primary Outcome Measure Information:
Title
Feasibility of reconstruction technique
Description
Measure the average operative time in minutes in each arm.
Time Frame
Time of procedure
Title
Pedicle dissection beyond the muscle
Description
Compare the number of pedicle dissection beyond the muscle in each group.
Time Frame
Time of procedure
Secondary Outcome Measure Information:
Title
Meningomyelocele Repair Dehiscence and/or CSF leak
Description
Compare the number of each complication in each arm
Time Frame
Time of procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed K Kamel
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Awni M Shawkat, MD
Organizational Affiliation
Assiut University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mahmoud A Mohamed
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Mohamed Abdeltawab
City
Assiut
ZIP/Postal Code
71515
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34024069
Citation
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.
Results Reference
background
PubMed Identifier
31574473
Citation
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.
Results Reference
background
PubMed Identifier
24683103
Citation
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.
Results Reference
background

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Propellers Flaps for Meningomylocele Defects

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