Clinical Assessment of Usage of Cleft Margin Flap With Anterior Palatal Closure in Closure of Naso-alveolar Defect.
NCT ID: NCT03922438
Last Updated: 2019-11-27
Study Results
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Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2018-10-10
2020-04-30
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Cleft margin flap with anterior palatal closure
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Medically fit for Surgery
* Patient with Primary, complete cleft lip
* Patient's age younger than six months
Exclusion Criteria
* Previous operated cases
* Incomplete cleft lip
* Patient older than six months
* Patients with any systemic condition
2 Months
6 Months
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Dina Yacoub Girgis
Principal investigator
Principal Investigators
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Mohamed G Beheiri, PhD
Role: STUDY_DIRECTOR
Faculty of Oral and Dental Medicine- Cairo University
Mamdouh A AboulHassan, PhD
Role: STUDY_DIRECTOR
Cairo University
Khaled A Salah Eldein, PhD
Role: STUDY_DIRECTOR
Faculty of Oral and Dental Medicine- Cairo University
Sherif A Hassan, PhD
Role: STUDY_DIRECTOR
Faculty of Oral and Dental Medicine- Cairo University
Dina Y Girgis, B.D.S
Role: PRINCIPAL_INVESTIGATOR
Faculty of Oral and Dental Medicine- Cairo University
Locations
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Faculty of Oral and Dental Medicine- Cairo University
Cairo, Giza Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Mossey 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.
Mossey 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.
Wehby 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.
Wilhelmsen HR, Musgrave RH. Complications of cleft lip surgery. Cleft Palate J. 1966 Jul;3:223-31. No abstract available.
Kuna 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.
Isik 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.
Park 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.
Related Links
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Quality of life in adults with repaired complete cleft lip and palate
Epidemiology underpinning research in the aetiology of orofacial clefts
Epidemiology of oral clefts 2012: an international perspective
The Impact of Orofacial Clefts on Quality of Life and Health Care Use and Costs
Complications of cleft lip surgery.
Primary repair of the alveolar cleft
Double-layered reconstruction of the nasal floor in complete cleft deformity of the primary palate using superfluous lip tissue
Other Identifiers
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CEBD-CU-2019-04-12
Identifier Type: -
Identifier Source: org_study_id
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