Using Reverse Flow Based Flap VS Palatal Pedicled Flap for Closure of Recurrent Small & Medium Sized Oronasal Fistula.
Condition: Patient Satisfaction
MeSH terms: Fistula
Study type: Interventional

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.
    

Intervention name(s): Curing small and medium sized oronasal fistula
Intervention type(s): Procedure
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Treatment