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Using Reverse Flow Based Flap VS Palatal Pedicled Flap for Closure of Recurrent Small & Medium Sized Oronasal Fistula.

NCT04814901 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-11-23

No results posted yet for this study

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

Conditions

  • Patient Satisfaction

Interventions

PROCEDURE

Curing small and medium sized oronasal fistula

* 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.

Sponsors & Collaborators

  • Doaa Jawad Roomi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-03
Primary Completion
2021-03-03
Completion
2021-03-03

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04814901 on ClinicalTrials.gov