Clinical trial NCT05188300: 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
Overall status: COMPLETED
Phase: NA
Conditions: Meningocele
Meningomyelocele
Keywords: Reconstructive Surgical Procedures / adverse effects
Meningomyelocele / surgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility of reconstruction technique
timeFrame: Time of procedure
measure: Pedicle dissection beyond the muscle
timeFrame: Time of procedure
Secondary outcomes:
measure: Meningomyelocele Repair Dehiscence and/or CSF leak
timeFrame: Time of procedure
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Mohamed Abdeltawab
Study officials:
affiliation: Assiut University
name: Mohamed K Kamel
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Awni M Shawkat, MD
role: STUDY_CHAIR
affiliation: Assiut University
name: Mahmoud A Mohamed
role: STUDY_DIRECTOR
References:
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.
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.
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.