Propellers Flaps for Meningomylocele Defects

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

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.

Study Overview

• Status: Completed
• Conditions: Meningocele; Meningomyelocele
• Intervention / Treatment: Procedure: Freestyle pedicled perforators propellers flaps for meningomyelocele defects

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Mohamed Abdeltawab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 6 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Freestyle pedicled perforators propellers flaps for meningomyelocele defects reconstruction with sequential advance in perforators dissection, large number cases, and detailed successful technique.
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; Freestyle pedicled perforators propellers flaps for meningomyelocele defects reconstruction with sequential advance in perforators dissection, large number cases, and detailed successful technique.
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; Freestyle pedicled perforators propellers flaps for meningomyelocele defects reconstruction with sequential advance in perforators dissection, large number cases, and detailed successful technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Meningomyelocele Repair Dehiscence and/or CSF leak	Compare the number of each complication in each arm	Time of procedure

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Mohamed K Kamel, Assiut University; Study Chair: Awni M Shawkat, MD, Assiut University; Study Director: Mahmoud A Mohamed, Assiut University

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): October 1, 2021
• Study Completion (ACTUAL): November 1, 2021

Study Registration Dates

• First Submitted: December 26, 2021
• First Submitted That Met QC Criteria: December 26, 2021
• First Posted (ACTUAL): January 12, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2022
• Last Update Submitted That Met QC Criteria: December 26, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Reconstructive Surgical Procedures / adverse effects; Meningomyelocele / surgery
• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Nervous System Malformations; Hernia; Neural Tube Defects; Spinal Dysraphism; Meningomyelocele; Spina Bifida Cystica; Meningocele
• Other Study ID Numbers: propellers flap

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