Patient SatisfactionNCT04814901
Using Reverse Flow Based Flap VS Palatal Pedicled Flap for Closure of Recurrent Small & Medium Sized Oronasal Fistula.
A study testing Curing small and medium sized oronasal fistula in people with Patient Satisfaction, run by Doaa Jawad Roomi at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- Curing small and medium sized oronasal fistula
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Dec 2020to 3 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Patients with systemic condition counteracting with the surgical procedure.
- Patients who underwent a previously ipsilateral cheek flap except for midline fistulae.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Patient Satisfaction
- Being tested
- Curing small and medium sized oronasal fistula
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curing small and medium sized oronasal fistulaProcedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | 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. Receives: Procedure: Curing small and medium sized oronasal fistula |
| Comparator group | Active comparator | 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 Receives: Procedure: Curing small and medium sized oronasal fistula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start3 Dec 2020
- Primary completion3 Mar 2021
- Study completion3 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Doaa Jawad Roomi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Doaa Jawad Roomi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814901
- Sponsor's protocol ID
- OMFS 3-3-8
- Status last verified
- Nov 2021
- First submitted
- 11 Mar 2021
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18177198Xiong 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.
PubMed 12471822Wang 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.
PubMed 12958822Richardson 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.
PubMed 25018605Cohen 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.
PubMed 2034725Dupoirieux 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.
PubMed 10203218Jackson 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.
PubMed 4554003Rayner 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.
PubMed 6692059Sasaki 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.
PubMed 6629796Bozola 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.
PubMed 2748738Pribaz 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.
PubMed 1513887Ariffuddin 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.
PubMed 29703876Yilmaz 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.
PubMed 12884211Shetty 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.
PubMed 23418920Ashtiani 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.
PubMed 16079659
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04814901
- Acronym / sponsor ID
- OMFS 3-3-8
- Conditions
- Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Doaa Jawad RoomiUniversity, hospital or other
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 3 Mar 2021 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Curing small and medium sized oronasal fistulaSurgical 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. |
| Comparator group | Active comparator | Procedure: Curing small and medium sized oronasal fistulaSurgical 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with systemic condition counteracting with the surgical procedure.
- Patients who underwent a previously ipsilateral cheek flap except for midline fistulae.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Comparator group, Study group |
Primary outcome
questionnaire
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Background: PubMed 18177198Smith 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.
- Background: PubMed 12471822Xiong 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.
- Background: PubMed 12958822Wang 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.
- Background: PubMed 25018605Richardson 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.
- Background: PubMed 2034725Cohen 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.
- Background: PubMed 10203218Dupoirieux 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.
- Background: PubMed 4554003Jackson 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.
- Background: PubMed 6692059Rayner 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.
- Background: PubMed 6629796Sasaki 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.
- Background: PubMed 2748738Bozola 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.
- Background: PubMed 1513887Pribaz 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.
- Background: PubMed 29703876Ariffuddin 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.
- Myomucosal island flap of the buccinator Muscle: An anatomical studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curing small and medium sized oronasal fistula in people with Patient Satisfaction, run by Doaa Jawad Roomi at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
questionnaire (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04814901, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.