Auricular Reconstruction in Microtia by Medpor Implant Following Tissue Expansion
1 other identifier
interventional
3
1 country
1
Brief Summary
The study involves patients with microtia of certain criteria will undergo tissue expansion by silicone bags in the postauricular region then Medpor implants will be applied undercover of the expanded skin for reconstruction of the auricule instead of the costal cartilage graft
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2021
CompletedFirst Posted
Study publicly available on registry
October 5, 2021
CompletedStudy Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedOctober 5, 2021
September 1, 2021
1.9 years
August 23, 2021
October 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy of Medpor implant after tissue expansion in treatment of Microtia through comparison with the normal ear regarding skin color, shape, size and patient or relatives satisfaction which will be assessed by likert scale
• The research will describe and assess the new technique for reconstruction of microtia by Medpor implant which is a new service not performed in Assiut university that skips the complications of the traditional rib cartilage multistage technique , Also it will assess the degree of patient and family satisfaction. Research on this new service has not been performed in Assiut university.
Three years
Study Arms (1)
Implant
OTHERUse of Medpor implant in auricle reconstruction in microtia
Interventions
Eligibility Criteria
You may qualify if:
- Unilateral microtia
- Age not less than six years
- Non-syndromatic microtia
You may not qualify if:
- Bilateral microtia
- Age less than six years
- Syndromatic microtia
- Previous ear surgery through postauricular incision
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AssiutU
Asyut, 71515, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Lecturer of ENT
Study Record Dates
First Submitted
August 23, 2021
First Posted
October 5, 2021
Study Start
November 1, 2021
Primary Completion
October 1, 2023
Study Completion
January 1, 2024
Last Updated
October 5, 2021
Record last verified: 2021-09