NCT06405698

Brief Summary

evaluation of perforator flaps versus perforator plus flaps

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

1.5 years

First QC Date

April 29, 2024

Last Update Submit

May 6, 2024

Conditions

Myelomeningocele

Keywords

myelomeningoceleperforator flapsinfants

Outcome Measures

Primary Outcomes (2)

  • changing complication rate

    evaluate of different flaps modalities in back defects closure

    baseline and 3 months

  • changing hospital stay time

    baseline and one month

Study Arms (2)

closure of the myelomeningocele defect by perforator flap.

EXPERIMENTAL

fifteen patient with myelomeningocele defect

Procedure: surgical closure of myelomeningocele defects by perforator flaps

closure of the myelomeningocele defect by perforator plus flap .

EXPERIMENTAL

fifteen patient with myelomeningocele defect

Procedure: surgical closure of myelomeningocele defects by perforator-plus flaps

Interventions

surgical closure of myelomeningocele defects by perforator flapsPROCEDURE

closure of myelomeningocele defect by perforator island flap after complete incision of the flap all around based on perforator vessel .

closure of the myelomeningocele defect by perforator flap.
surgical closure of myelomeningocele defects by perforator-plus flapsPROCEDURE

closure of myelomeningocele defect by perforator-plus island flap harvesting leaving skin bridge connecting to the flap and dissection of the perforator vessel

closure of the myelomeningocele defect by perforator plus flap .

Eligibility Criteria

Age2 Days - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • infants up to one year,
  • dorso-lumbar myelomeningocele.
  • moderate to large myelomeningocele defects. (25 - 39 cm2 ) .

You may not qualify if:

  • cervical myelomeningocele
  • very large defects (more than 40 cm2 )
  • preterm newborn patients.
  • hematological disease
  • any problem against prone position of the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Isik D, Tekes L, Eseoglu M, Isik Y, Bilici S, Atik B. Closure of large myelomeningocele defects using dorsal intercostal artery perforator flap. Ann Plast Surg. 2011 Aug;67(2):159-63. doi: 10.1097/SAP.0b013e3181f3e0cf.

    PMID: 21301309BACKGROUND

  • Cologlu H, Ozkan B, Uysal AC, Cologlu O, Borman H. Bilateral propeller flap closure of large meningomyelocele defects. Ann Plast Surg. 2014 Jul;73(1):68-73. doi: 10.1097/SAP.0b013e31826caf5a.

    PMID: 24918736BACKGROUND

  • Basterzi Y, Tenekeci G. Dorsal Intercostal Artery Perforator Propeller Flaps: A Reliable Option in Reconstruction of Large Meningomyelocele Defects. Ann Plast Surg. 2016 Apr;76(4):434-7. doi: 10.1097/SAP.0000000000000417.

    PMID: 26010351BACKGROUND

  • Kehrer A, Heidekrueger PI, Lonic D, Taeger CD, Klein S, Lamby P, Sachanadani NS, Jung EM, Prantl L, Batista da Silva NP. High-Resolution Ultrasound-Guided Perforator Mapping and Characterization by the Microsurgeon in Lower Limb Reconstruction. J Reconstr Microsurg. 2021 Jan;37(1):75-82. doi: 10.1055/s-0040-1702162. Epub 2020 Feb 28.

    PMID: 32110822BACKGROUND

MeSH Terms

Conditions

Meningomyelocele

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • mahmoud Abdelaal, doctor

    professor

    STUDY DIRECTOR

Central Study Contacts

mohamed tawfik, doctor

CONTACT

01029980167mtawfik206@aun.edu.eg

Osama taha, professor

CONTACT

01069468684osamataha@osamataha.health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 8, 2024

Study Start

May 1, 2024

Primary Completion

November 1, 2025

Study Completion

May 1, 2026

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share