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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Patient Satisfaction

Intervention / Treatment
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* Procedure: Curing small and medium sized oronasal fistula


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 arms parallel group of patients will be assigned to this trial: The trial will be in superiority in an allocation of 1:1 ratio.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Surgical closure of patients with recurrent small to medium sized oronasal fistulae using FAMM and assessment of success regarding patient satisfaction and healing and absence of complications such as venous congestion, dehiscence, facial nerve injury and infection. | Procedure: Curing small and medium sized oronasal fistula<br>* 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.<br>|
| Active Comparator: Comparator group<br>Surgical closure of patients with recurrent small to medium sized oronasal fistulae and its effect on patient's satisfaction and healing and absence of complications such as venous congestion, dehiscence, facial nerve injury and infection | Procedure: Curing small and medium sized oronasal fistula<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| questionnaire | 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 | 3 months |