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

2021年11月20日 更新者:Doaa Jawad Roomi

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.

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

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Cairo、埃及、11553
        • Faculty of Dentistry

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 60年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Study group
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.
  • 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.
有源比较器:Comparator group
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
  • 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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
questionnaire
大体时间: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
3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年12月3日

初级完成 (实际的)

2021年3月3日

研究完成 (实际的)

2021年3月3日

研究注册日期

首次提交

2021年3月11日

首先提交符合 QC 标准的

2021年3月22日

首次发布 (实际的)

2021年3月24日

研究记录更新

最后更新发布 (实际的)

2021年11月23日

上次提交的符合 QC 标准的更新

2021年11月20日

最后验证

2021年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • OMFS 3-3-8

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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