Propellers Flaps for Meningomylocele Defects

Meningomyelocele Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05188300
• Other study ID #: propellers flap
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: November 1, 2021

Study information

• Verified date: December 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Meningocele
• Meningomyelocele

Intervention

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.

Locations

Country	Name	City	State
Egypt	Mohamed Abdeltawab	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View 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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of reconstruction technique	Measure the average operative time in minutes in each arm.	Time of procedure
Primary	Pedicle dissection beyond the muscle	Compare the number of pedicle dissection beyond the muscle in each group.	Time of procedure
Secondary	Meningomyelocele Repair Dehiscence and/or CSF leak	Compare the number of each complication in each arm	Time of procedure