Propellers Flaps for Meningomylocele Defects

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05188300
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 3
• Actual Duration (Months): 34
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Meningocele; Meningomyelocele	Procedure: Freestyle pedicled perforators propellers flaps for meningomyelocele defects	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Free Style Pedicled Perforators Propellers Flaps for Meningomylocele Defects Reconstruction With Sequential Advance in Perforators Dissection
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Oct 1, 2021
• Actual Study Completion Date: Nov 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Feasibility of reconstruction technique [Time of procedure]

   Measure the average operative time in minutes in each arm.

2. Pedicle dissection beyond the muscle [Time of procedure]

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

Secondary Outcome Measures

1. Meningomyelocele Repair Dehiscence and/or CSF leak [Time of procedure]

   Compare the number of each complication in each arm

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 6 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mohamed Abdeltawab	Assiut		Egypt	71515

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Review.
• Kushida-Contreras BH, Gaxiola-García 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.

• Responsible Party: Mohamed Abdel-Tawab Mohamed, Lecturer, Assiut University
• ClinicalTrials.gov Identifier: NCT05188300
• Other Study ID Numbers: propellers flap
• First Posted: Jan 12, 2022
• Last Update Posted: Jan 12, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mohamed Abdel-Tawab Mohamed, Lecturer, Assiut University: Reconstructive Surgical Procedures / adverse effects; Meningomyelocele / surgery
• Additional relevant MeSH terms: Meningomyelocele; Spina Bifida Cystica; Meningocele

Study Results

No Results Posted as of Jan 12, 2022