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Clinical Trials/NCT04814901
NCT04814901CompletedNot Applicable

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 Roomi2 sites in 1 country20 target enrollmentStarted: December 3, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
20
Locations
2
Primary Endpoint
questionnaire

Study Overview

Brief 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

Detailed Description

Oronasal fistulae (particularly those of the anterior palate) are often difficult to close because the buccal cavity is narrow and the palatal mucosa is not extensible.

Historically, skin flaps (forehead or nasolabial skin flaps) were first used to close such defects. but they leave a conspicuous scar. Mucosal flaps, which were empirically harvested from the cheek mucosa have also been used occasionally, but unpredictable results discouraged further attempts. A more accurate description of the vascularization of the buccal mucosal has allowed the design of axial-pattern flaps. The buccinator musculomucosal flap was first introduced as an island flap supported by the facial pedicle, and was then used successfully as an axial pattern flap that was vascularized by the buccal artery according to Bozola et al. or the facial artery according to Carstens et al.

The FAMM (facial artery musculomucosal) flap was introduced by Pribaz et al. in 1992 and its main advantage is its long rotational arc that allows closure of defects of the anterior palate that were formerly a reconstructive challenge. Pribaz et al. gave an accurate description of the dissection of the flap, but variations in the course of the facial artery sometimes preclude its use. Previous studies involving FAMM flap were applied to oronasal fistula repair either recurrent or as first attempt were described in repair of alveolar clefts, anterior palatal fistulae and in recurrent fistulae after palatoplasty in cleft patients either superior or inferior pediceled flap. In cases of hypovascular bed, it increases the chances for failure of other techniques of closure. The palatal pedilced flap was reported in the literature as one of the regional flaps for closure of oronasal fistulae. The previous studies included case series, with no any randomized clinical trial.

This study compares using FAMM flap versus Palatal Pedicled flap in a randomized clinical trial in closure of recurrent oronasal fistulae.

Aim of the study To evaluate the effect of using FAMM for closure of recurrent small and medium sized oronasal fistula on patient's satisfaction versus using the palatal pedicled flap.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients with recurrent small and medium sized oronasal fistula failed after several attempts closure, up to 10 mm regardless of number of recurrence and position of the fistula.
  • Age group : from 18 to 60 years old.
  • No sex predilection.
  • Patients with no contraindications to surgical intervention.
  • Patients accepting consent for extracting one teeth in the surgical field if needed.
  • Patients proved with Doppler study with a patent facial artery course.

Exclusion Criteria

  • Patients with systemic condition counteracting with the surgical procedure.
  • Patients who underwent a previously ipsilateral cheek flap except for midline fistulae.

Outcomes

Primary Outcomes

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Time Frame: 3 months

Meet the patients satisfaction regarding both success and function after closure of recurrent small and medium sized oronasal fistula using the Facial artery Musculomucosal (FAMM) Flap

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Doaa Jawad Roomi
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Doaa Jawad Roomi

Principal Investigator

Cairo University

Study Sites (2)

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