Clinical Assessment of Usage of Cleft Margin Flap With Anterior Palatal Closure in Closure of Naso-alveolar Defect.

November 25, 2019 updated by: Dina Yacoub Girgis, Cairo University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Giza
      • Cairo, Giza, Egypt, 11553
        • Recruiting
        • Faculty of Oral and Dental Medicine- Cairo University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dina Y Girgis, B.D.S

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 6 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non syndromic patients
  • Medically fit for Surgery
  • Patient with Primary, complete cleft lip
  • Patient's age younger than six months

Exclusion Criteria:

  • Patient with syndromic cleft lip
  • Previous operated cases
  • Incomplete cleft lip
  • Patient older than six months
  • Patients with any systemic condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cleft margin flap with anterior palatal closure
Usage of cleft margin flap with anterior palatal closure during primary cleft lip repair.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months postoperative.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Mohamed G Beheiri, PhD, Faculty of Oral and Dental Medicine- Cairo University
  • Study Director: Mamdouh A AboulHassan, PhD, Cairo University
  • Study Director: Khaled A Salah Eldein, PhD, Faculty of Oral and Dental Medicine- Cairo University
  • Study Director: Sherif A Hassan, PhD, Faculty of Oral and Dental Medicine- Cairo University
  • Principal Investigator: Dina Y Girgis, B.D.S, Faculty of Oral and Dental Medicine- Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 10, 2018

Primary Completion (ANTICIPATED)

April 1, 2020

Study Completion (ANTICIPATED)

April 1, 2020

Study Registration Dates

First Submitted

April 15, 2019

First Submitted That Met QC Criteria

April 17, 2019

First Posted (ACTUAL)

April 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 27, 2019

Last Update Submitted That Met QC Criteria

November 25, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-2019-04-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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