Using Reverse Flow Based Flap VS Palatal Pedicled Flap for Closure of Recurrent Small & Medium Sized Oronasal Fistula.
NCT ID: NCT04814901
Last Updated: 2021-11-23
Study Results
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Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2020-12-03
2021-03-03
Brief Summary
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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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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 who underwent a previously ipsilateral cheek flap except for midline fistulae.
18 Years
60 Years
ALL
No
Sponsors
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Doaa Jawad Roomi
OTHER
Responsible Party
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Doaa Jawad Roomi
Principal Investigator
Locations
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Faculty of Dentistry
Cairo, , Egypt
Countries
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References
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Smith DM, Vecchione L, Jiang S, Ford M, Deleyiannis FW, Haralam MA, Naran S, Worrall CI, Dudas JR, Afifi AM, Marazita ML, Losee JE. The Pittsburgh Fistula Classification System: a standardized scheme for the description of palatal fistulas. Cleft Palate Craniofac J. 2007 Nov;44(6):590-4. doi: 10.1597/06-204.1.
Xiong B, Zhao M, Cheng T, Gao P. [Analysis of 5459 cleft lip and palate cases]. Zhonghua Zheng Xing Wai Ke Za Zhi. 2002 Sep;18(5):294-6. Chinese.
Wang HT, Li F. [Clinical study on fistula incidence of early cleft palate repair]. Zhonghua Zheng Xing Wai Ke Za Zhi. 2003 May;19(3):192-4. Chinese.
Richardson S, Agni NA. Palatal fistulae: a comprehensive classification and difficulty index. J Maxillofac Oral Surg. 2014 Sep;13(3):305-9. doi: 10.1007/s12663-013-0535-2. Epub 2013 May 26.
Cohen SR, Kalinowski J, LaRossa D, Randall P. Cleft palate fistulas: a multivariate statistical analysis of prevalence, etiology, and surgical management. Plast Reconstr Surg. 1991 Jun;87(6):1041-7.
Dupoirieux L, Plane L, Gard C, Penneau M. Anatomical basis and results of the facial artery musculomucosal flap for oral reconstruction. Br J Oral Maxillofac Surg. 1999 Feb;37(1):25-8. doi: 10.1054/bjom.1998.0301.
Jackson IT. Closure of secondary palatal fistulae with intra-oral tissue and bone grafting. Br J Plast Surg. 1972 Apr;25(2):93-105. doi: 10.1016/s0007-1226(72)80028-6. No abstract available.
Rayner CR. Oral mucosal flaps in midfacial reconstruction. Br J Plast Surg. 1984 Jan;37(1):43-7. doi: 10.1016/0007-1226(84)90039-0.
Sasaki TM, Taylor L, Martin L, Baker HW, McConnell DB, Vetto RM. Correction of cervical esophageal stricture using an axial island cheek flap. Head Neck Surg. 1983 Sep-Oct;6(1):596-9. doi: 10.1002/hed.2890060110.
Bozola AR, Gasques JA, Carriquiry CE, Cardoso de Oliveira M. The buccinator musculomucosal flap: anatomic study and clinical application. Plast Reconstr Surg. 1989 Aug;84(2):250-7. doi: 10.1097/00006534-198908000-00010.
Pribaz J, Stephens W, Crespo L, Gifford G. A new intraoral flap: facial artery musculomucosal (FAMM) flap. Plast Reconstr Surg. 1992 Sep;90(3):421-9. doi: 10.1097/00006534-199209000-00009.
Ariffuddin I, Arman Zaharil MS, Wan Azman WS, Ahmad Sukari H. The use of facial artery musculomucosal (FAMM) readvancement flap in closure of recurrent oronasal fistula. Med J Malaysia. 2018 Apr;73(2):112-113.
Yilmaz T, Suslu AE, Gursel B. Treatment of oroantral fistula:experience with 27 cases. Am J Otolaryngol. 2003 Jul-Aug;24(4):221-3. doi: 10.1016/s0196-0709(03)00027-9.
Shetty R, Lamba S, Gupta AK. Role of facial artery musculomucosal flap in large and recurrent palatal fistulae. Cleft Palate Craniofac J. 2013 Nov;50(6):730-3. doi: 10.1597/12-115. Epub 2013 Feb 18.
Ashtiani AK, Emami SA, Rasti M. Closure of complicated palatal fistula with facial artery musculomucosal flap. Plast Reconstr Surg. 2005 Aug;116(2):381-6; discussion 387-8. doi: 10.1097/01.prs.0000142475.63276.87.
Sohail M, Bashir MM, Khan FA, Ashraf N. Comparison of Clinical Outcome of Facial Artery Myomucosal Flap and Tongue Flap for Closure of Large Anterior Palatal Fistulas. J Craniofac Surg. 2016 Sep;27(6):1465-8. doi: 10.1097/SCS.0000000000002773.
Lahiri A, Richard B. Superiorly based facial artery musculomucosal flap for large anterior palatal fistulae in clefts. Cleft Palate Craniofac J. 2007 Sep;44(5):523-7. doi: 10.1597/06-164.1.
Rauso R, Tartaro G, Califano L, Rugge L, Chirico F, Colella G. Pedicled palatal flap for surgical repair of oro-nasal fistula. J Biol Regul Homeost Agents. 2018 Nov-Dec;32(6):1565-1567.
Other Identifiers
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OMFS 3-3-8
Identifier Type: -
Identifier Source: org_study_id