Nasoalveolar Fistula (Defect)NCT03922438
Clinical Assessment of Usage of Cleft Margin Flap With Anterior Palatal Closure in Closure of Naso-alveolar Defect.
A study testing usage of cleft margin flap with anterior palatal closure during primary cleft lip repair. in people with Nasoalveolar Fistula (Defect), run by Cairo University at 1 site in Egypt.
Trial summary
During primary cleft lip repair in patients who were born with cleft lip and palate, usage of cleft margin flap with anterior palatal closure will be done in an attempt to close the Naso-alveolar fistula (defect) that usually occur and remain in those patients post-operatively. Read more about this study
- Who is it for?
- Ages 2 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Nasoalveolar Fistula (Defect)
- What is being tested?
- usage of cleft margin flap with anterior palatal closure during primary cleft lip repair.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2018to Apr 2020
- 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 2 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Non syndromic patients
- Medically fit for Surgery
- Patient with Primary, complete cleft lip
- Patient's age younger than six months
Who cannot join
- Patient with syndromic cleft lip
- Previous operated cases
- Incomplete cleft lip
- Patient older than six months
- Patients with any systemic condition
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Oral and Dental Medicine- Cairo University
Cairo, Giza Governorate, 11553
Dina Y Girgis, B.D.S, +201278061226, dina.yacoub@dentistry.cu.edu.eg
Mamdouh A AboulHassan, PhD, +201221022210, aboulhassanm2@gmail.com
About this study
Official title: Use of Cleft Margin Flap With Anterior Palatal Closure for Closure of Naso-alveolar Defect During Primary Cleft Lip Repair (Pilot Study).
During primary cleft lip repair in patients who were born with cleft lip and palate, usage of cleft margin flap with anterior palatal closure will be done in an attempt to close the Naso-alveolar fistula (defect) that usually occur and remain in those patients post-operatively.
Read the detailed description
Cleft margin flap (that was discarded in the modified Millard's technique for cleft lip repair) with anterior palatal closure will be used during primary cleft lip repair in patients who were born with cleft lip and palate in an attempt to close the Naso-alveolar fistula (defect) that usually occur and remain in those patients post-operatively and this will be assessed in the predetermined follow up period.
Interventions:
General operative procedures
Eligible patients will be included in the study group:
- With the patient supine, general anesthesia will be induced, An uncuffed, oral, right angle endotracheal tube (RAE) will be placed and taped in the midline to the chin.
- The tube is further immobilized with a mouth pack.
- Head ring and shoulder rolls are placed. Sterile tapes will be placed over the closed eyelids. The face is prepared and draped.
- Reference points will be marked using brilliant green dye on a sharpened applicator stick.
- After careful marking, Approximately 3ml of 1% lidocaine with 1:200000 Epinephrines will be injected into the lip and alar base for homeostasis governed by heart rate of the patient.
- The lateral lip flap will first elevated with mucosal incision using number 15 blade scalpel at the gingivo-labial sulcus on the oral side and the release of the lateral lip segments will be achieved by dissecting over the lateral maxilla in the supra-periosteal plane.
- After this, a scalpel will be used to provide 1-2 mm of release of the skin from the underlying orbicularis oris muscle. This facilitates a 3 layer closure of mucosa, orbicularis oris muscle, and dermis. Then, the soft tissue attachments of the nasal base are separated from the piriform aperture. When the nasal dissection is complete, the surgeon is ready for closure of the lip deformity.
- Vomerine flap is done by doing incision on palatal side of the maxilla and vomer bone, then elevating mucoperiosteal flap on hard palate \& undermining palatal mucosa.
- Closure of nasal lining.
- Mucosal flap obtained from part of the cleft near the lip was used as an inferior-based local flap. This flap was sutured to the anterior end of the mucoperiosteal flaps of the palate after it was passed from the alveolar cleft. The gingival mucosa on the alveolar cleft part was de-epithelialized, and lateral suturing of the flap was completed. In this way, not only the alveolar cleft but also the anterior palate cleft was corrected in this session.
- Skin hooks will be used to oppose the lip segments together to ensure that there is adequate release and minimal tension across the cleft wound. If too much tension exists, further dissection laterally or medially over the maxilla and superiorly along the bony piriform may be performed.
- Closure begins with 4-0 vicryl resorbable sutures placed in simple interrupted manner with the buried knots, to reconstituting the orbicularis oris muscular sphincter.
After this, the dermis will be closed by using 6-0 vicryl sutures. Approximation of the vermilion cutaneous borders must be precise, as any misalignment will become accentuated with subsequent growth.
5-0 vicryl sutures placed in the vermillion and the mucosa of the lip completing the closure.
Postoperative care:
- Cephalosporin antibiotic (Ceclor 125mg q12h) for five days.
- Otrivin saline nasal drops for 5 days.
- Mycostatin (Nystatin) Cream q8h for 5 days.
- Paracetamol drops 15ml.
- Fucidin cream ( sodium fusidate topical ) 3 times per day.
- Use of sterile tape as simple coverage for the wound for 5 days.
- Wash surgical wounds with soap \& water until wound closes and heals.
- Massage the lip and columella with the cream downward with thumb once wound heals for 4-5 minutes twice a day for 3 months.
All patients will be evaluated at the following intervals:
- One week following Surgery
- One month following Surgery
- Six months following Surgery
- Conditions
- Nasoalveolar Fistula (Defect)
- Being tested
- usage of cleft margin flap with anterior palatal closure during primary cleft lip repair.
- Keywords
- Cleft lip and palate, Cleft lip, Cleft alveolus, Cheiloplasty, Nasoalveolar fistula
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usage of cleft margin flap with anterior palatal closure during primary cleft lip repair.Procedure or surgery
Under general anesthesia, preparation of lip and palatal flaps will be done and then cleft margin flap which is designed to be inferiorly based will be used with anterior palatal closure in an attempt to decrease the incidence rate of naso-alveolar fistula (defect) that is usually occur and remain in those patients post-operatively.
| Study group | Role | What they receive |
|---|---|---|
| Cleft margin flap with anterior palatal closure | Experimental | Usage of cleft margin flap with anterior palatal closure during primary cleft lip repair. Receives: Procedure: usage of cleft margin flap with anterior palatal closure during primary cleft lip repair. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Naso-alveolar fistula
Naso-alveolar fistula will be assessed initially in the outpatient clinic by clinical examination and finally it will be re-assessed by usage of Methylene blue dye at time of cleft palate repair to assess the presence of any fistula.
Measured: 6 months postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start10 Oct 2018
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Nasoalveolar Fistula (Defect)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study The eligible patients will be included in the study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Yacoub Girgis, Cairo University
- Investigators
- Mohamed G Beheiri, PhD, Study director, Faculty of Oral and Dental Medicine- Cairo UniversityMamdouh A AboulHassan, PhD, Study director, Cairo UniversityKhaled A Salah Eldein, PhD, Study director, Faculty of Oral and Dental Medicine- Cairo UniversitySherif A Hassan, PhD, Study director, Faculty of Oral and Dental Medicine- Cairo UniversityDina Y Girgis, B.D.S, Principal investigator, Faculty of Oral and Dental Medicine- Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922438
- Sponsor's protocol ID
- CEBD-CU-2019-04-12
- Status last verified
- Nov 2019
- First submitted
- 15 Apr 2019
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marcusson A, Akerlind I, Paulin G. Quality of life in adults with repaired complete cleft lip and palate. Cleft Palate Craniofac J. 2001 Jul;38(4):379-85. doi: 10.1597/1545-1569_2001_038_0379_qoliaw_2.0.co_2.
PubMed 11420018Mossey P. Epidemiology underpinning research in the aetiology of orofacial clefts. Orthod Craniofac Res. 2007 Aug;10(3):114-20. doi: 10.1111/j.1601-6343.2007.00398.x.
PubMed 17651127Mossey PA, Modell B. Epidemiology of oral clefts 2012: an international perspective. Front Oral Biol. 2012;16:1-18. doi: 10.1159/000337464. Epub 2012 Jun 25.
PubMed 22759666Wehby GL, Cassell CH. The impact of orofacial clefts on quality of life and healthcare use and costs. Oral Dis. 2010 Jan;16(1):3-10. doi: 10.1111/j.1601-0825.2009.01588.x. Epub 2009 Jul 27.
PubMed 19656316Wilhelmsen HR, Musgrave RH. Complications of cleft lip surgery. Cleft Palate J. 1966 Jul;3:223-31. No abstract available.
PubMed 5220833Kuna SK, Srinath N, Naveen BS, Hasan K. Comparison of Outcome of Modified Millard's Incision and Delaire's Functional Method in Primary Repair of Unilateral Cleft Lip: A Prospective Study. J Maxillofac Oral Surg. 2016 Jun;15(2):221-8. doi: 10.1007/s12663-015-0816-z. Epub 2015 Jul 25.
PubMed 27298546Isik D, Atik B, Tan O, Aktar S, Dogan M, Goktas U. Primary repair of the alveolar cleft. J Craniofac Surg. 2011 Nov;22(6):2224-6. doi: 10.1097/SCS.0b013e31823200c3.
PubMed 22075837Park YW, Kwon KJ, Kim MK. Double-layered reconstruction of the nasal floor in complete cleft deformity of the primary palate using superfluous lip tissue. Maxillofac Plast Reconstr Surg. 2015 Oct 13;37(1):35. doi: 10.1186/s40902-015-0035-z. eCollection 2015 Dec.
PubMed 26491651
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Cleft Margin Flap With Anterior Palatal Closure for Closure of Naso-alveolar Defect During Primary Cleft Lip Repair (Pilot Study).
- ClinicalTrials.gov ID
- NCT03922438
- Acronym / sponsor ID
- CEBD-CU-2019-04-12
- Conditions
- Nasoalveolar Fistula (Defect)
- Keywords
- Cleft lip and palate, Cleft lip, Cleft alveolus, Cheiloplasty, Nasoalveolar fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 22 Apr 2019 (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.
During primary cleft lip repair in patients who were born with cleft lip and palate, usage of cleft margin flap with anterior palatal closure will be done in an attempt to close the Naso-alveolar fistula (defect) that usually occur and remain in those patients post-operatively.
Detailed description
Cleft margin flap (that was discarded in the modified Millard's technique for cleft lip repair) with anterior palatal closure will be used during primary cleft lip repair in patients who were born with cleft lip and palate in an attempt to close the Naso-alveolar fistula (defect) that usually occur and remain in those patients post-operatively and this will be assessed in the predetermined follow up period.
Interventions:
General operative procedures
Eligible patients will be included in the study group:
- With the patient supine, general anesthesia will be induced, An uncuffed, oral, right angle endotracheal tube (RAE) will be placed and taped in the midline to the chin.
- The tube is further immobilized with a mouth pack.
- Head ring and shoulder rolls are placed. Sterile tapes will be placed over the closed eyelids. The face is prepared and draped.
- Reference points will be marked using brilliant green dye on a sharpened applicator stick.
- After careful marking, Approximately 3ml of 1% lidocaine with 1:200000 Epinephrines will be injected into the lip and alar base for homeostasis governed by heart rate of the patient.
- The lateral lip flap will first elevated with mucosal incision using number 15 blade scalpel at the gingivo-labial sulcus on the oral side and the release of the lateral lip segments will be achieved by dissecting over the lateral maxilla in the supra-periosteal plane.
- After this, a scalpel will be used to provide 1-2 mm of release of the skin from the underlying orbicularis oris muscle. This facilitates a 3 layer closure of mucosa, orbicularis oris muscle, and dermis. Then, the soft tissue attachments of the nasal base are separated from the piriform aperture. When the nasal dissection is complete, the surgeon is ready for closure of the lip deformity.
- Vomerine flap is done by doing incision on palatal side of the maxilla and vomer bone, then elevating mucoperiosteal flap on hard palate \& undermining palatal mucosa.
- Closure of nasal lining.
- Mucosal flap obtained from part of the cleft near the lip was used as an inferior-based local flap. This flap was sutured to the anterior end of the mucoperiosteal flaps of the palate after it was passed from the alveolar cleft. The gingival mucosa on the alveolar cleft part was de-epithelialized, and lateral suturing of the flap was completed. In this way, not only the alveolar cleft but also the anterior palate cleft was corrected in this session.
- Skin hooks will be used to oppose the lip segments together to ensure that there is adequate release and minimal tension across the cleft wound. If too much tension exists, further dissection laterally or medially over the maxilla and superiorly along the bony piriform may be performed.
- Closure begins with 4-0 vicryl resorbable sutures placed in simple interrupted manner with the buried knots, to reconstituting the orbicularis oris muscular sphincter.
After this, the dermis will be closed by using 6-0 vicryl sutures. Approximation of the vermilion cutaneous borders must be precise, as any misalignment will become accentuated with subsequent growth.
5-0 vicryl sutures placed in the vermillion and the mucosa of the lip completing the closure.
Postoperative care:
- Cephalosporin antibiotic (Ceclor 125mg q12h) for five days.
- Otrivin saline nasal drops for 5 days.
- Mycostatin (Nystatin) Cream q8h for 5 days.
- Paracetamol drops 15ml.
- Fucidin cream ( sodium fusidate topical ) 3 times per day.
- Use of sterile tape as simple coverage for the wound for 5 days.
- Wash surgical wounds with soap \& water until wound closes and heals.
- Massage the lip and columella with the cream downward with thumb once wound heals for 4-5 minutes twice a day for 3 months.
All patients will be evaluated at the following intervals:
- One week following Surgery
- One month following Surgery
- Six months following Surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study The eligible patients will be included in the study
| Arm | Type | Receives |
|---|---|---|
| Cleft margin flap with anterior palatal closure | Experimental | Procedure: usage of cleft margin flap with anterior palatal closure during primary cleft lip repair.Usage of cleft margin flap with anterior palatal closure during primary cleft lip repair. |
Who may qualify
- Ages
- 2 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Non syndromic patients
- Medically fit for Surgery
- Patient with Primary, complete cleft lip
- Patient's age younger than six months
Key exclusion criteria (5 listed)
- Patient with syndromic cleft lip
- Previous operated cases
- Incomplete cleft lip
- Patient older than six months
- Patients with any systemic condition
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 |
|---|---|---|
| usage of cleft margin flap with anterior palatal closure during primary cleft lip repair.Under general anesthesia, preparation of lip and palatal flaps will be done and then cleft margin flap which is designed to be inferiorly based will be used with anterior palatal closure in an attempt to decrease the incidence rate of naso-alveolar fistula (defect) that is usually occur and remain in those patients post-operatively. | Procedure or surgery | Cleft margin flap with anterior palatal closure |
Primary outcome
Naso-alveolar fistula
Time frame: 6 months postoperative.
Naso-alveolar fistula will be assessed initially in the outpatient clinic by clinical examination and finally it will be re-assessed by usage of Methylene blue dye at time of cleft palate repair to assess the presence of any fistula.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Background: PubMed 11420018Marcusson A, Akerlind I, Paulin G. Quality of life in adults with repaired complete cleft lip and palate. Cleft Palate Craniofac J. 2001 Jul;38(4):379-85. doi: 10.1597/1545-1569_2001_038_0379_qoliaw_2.0.co_2.
- Background: PubMed 17651127Mossey P. Epidemiology underpinning research in the aetiology of orofacial clefts. Orthod Craniofac Res. 2007 Aug;10(3):114-20. doi: 10.1111/j.1601-6343.2007.00398.x.
- Background: PubMed 22759666Mossey PA, Modell B. Epidemiology of oral clefts 2012: an international perspective. Front Oral Biol. 2012;16:1-18. doi: 10.1159/000337464. Epub 2012 Jun 25.
- Background: PubMed 19656316Wehby GL, Cassell CH. The impact of orofacial clefts on quality of life and healthcare use and costs. Oral Dis. 2010 Jan;16(1):3-10. doi: 10.1111/j.1601-0825.2009.01588.x. Epub 2009 Jul 27.
- Background: PubMed 5220833Wilhelmsen HR, Musgrave RH. Complications of cleft lip surgery. Cleft Palate J. 1966 Jul;3:223-31. No abstract available.
- Background: PubMed 27298546Kuna SK, Srinath N, Naveen BS, Hasan K. Comparison of Outcome of Modified Millard's Incision and Delaire's Functional Method in Primary Repair of Unilateral Cleft Lip: A Prospective Study. J Maxillofac Oral Surg. 2016 Jun;15(2):221-8. doi: 10.1007/s12663-015-0816-z. Epub 2015 Jul 25.
- Background: PubMed 22075837Isik D, Atik B, Tan O, Aktar S, Dogan M, Goktas U. Primary repair of the alveolar cleft. J Craniofac Surg. 2011 Nov;22(6):2224-6. doi: 10.1097/SCS.0b013e31823200c3.
- Background: PubMed 26491651Park YW, Kwon KJ, Kim MK. Double-layered reconstruction of the nasal floor in complete cleft deformity of the primary palate using superfluous lip tissue. Maxillofac Plast Reconstr Surg. 2015 Oct 13;37(1):35. doi: 10.1186/s40902-015-0035-z. eCollection 2015 Dec.
- Quality of life in adults with repaired complete cleft lip and palateLink provided by the sponsor.
- Epidemiology underpinning research in the aetiology of orofacial cleftsLink provided by the sponsor.
- Epidemiology of oral clefts 2012: an international perspectiveLink provided by the sponsor.
- The Impact of Orofacial Clefts on Quality of Life and Health Care Use and CostsLink provided by the sponsor.
- Complications of cleft lip surgery.Link provided by the sponsor.
- Primary repair of the alveolar cleftLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Mohamed G Beheiri, PhD study director
Faculty of Oral and Dental Medicine- Cairo University
Mamdouh A AboulHassan, PhD study director
Cairo University
Khaled A Salah Eldein, PhD study director
Faculty of Oral and Dental Medicine- Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing usage of cleft margin flap with anterior palatal closure during primary cleft lip repair. in people with Nasoalveolar Fistula (Defect), run by Cairo University 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Nov 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina Y Girgis, B.D.S (+201278061226, dina.yacoub@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Naso-alveolar fistula (time frame: 6 months postoperative.). 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 NCT03922438, which also lists 8 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 27 Nov 2019.