CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Curing small and medium sized oronasal fistulaprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04814901
NCT04814901N/ACompleted
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Patient Satisfaction After Using Reverse Flow Based Facial Artery Musculomucosal Flap (FAMM) Versus Palatal Pedicled Flap for Closure of Recurrent Small and Medium Sized Oronasal Fistula. A Randomized Clinical Trial.

Doaa Jawad Roomi·interventional·Posted Mar 24, 2021·Updated Nov 23, 2021

In Brief

A clinical study evaluating Curing small and medium sized oronasal fistula for Patient Satisfaction. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Research question: What are the outcomes of using the Facial artery Musculomucosal (FAMM) Flap to close recurrent small and medium sized oronasal fistulae based on reverse flow on patient's satisfaction versus using the Palatal Pedicled flap? Statement of the problem: To determine whether the using the Facial artery Musculomucosal (FAMM) Flap to close recurrent small and medium sized oronasal fistulae which are difficult to manage could meet the patients satisfaction regarding both success and function versus using palatal pedicled flap

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPatient Satisfaction
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMar 24, 2021
Enrollment StartDec 3, 2020
Primary CompletionMar 3, 2021
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.3 years ago

Interventions

Curing small and medium sized oronasal fistulaprocedure

* Flap will be marked medial to the duct, which limits posterior extent of flap. Anterior flap marking starts 1cm posterior to oral commissure. * Width of flap was kept to about 2-2.5cm. * An initial incision will be made 1cm posterior to oral commissure. * Incision will be deepened through buccal mucosa, submucosa, \& underlying muscles into layer of buccal fat. * Flap will be dissected in a retrograde or antegrade manner depending on fistula site, maintaining vessels in a central position in the flap. * Once completely raised, flap inserted \& sutured in place while donor site be closed primarily with 4-0 polyglactin (Vicryl) interrupted sutures. * Patient's comparator group will be treated by raising a palatal pedicled flap. * Flap will be outlined extending from palatal mucosa against permanent 2nd molar till permanent canine anteriorly. * It is rotated towards oronasal fistula \& secured in place using 4 -0 Vicryl interrupted sutures.