Furlow With Buccinator and Fistula Formation

ConditionCleft Palate
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-12
SponsorFayoum University

About this trial

Furlow with buccal myomucosal flap (group 1) Local anesthesia with a vasoconstrictor will be injected at the beginning of the surgery after Z- flap outline marking. On the left side, myomucosal posteriorly based flap will be incised containing the levator palateni muscle with a 60◦ angle and elevated. Another small anteriorly-based nasal mucosa flap will be created. On the opposite side, oral mucosal anteriorly based flap with a 90◦ angle will be incised and elevated. Palatal muscle will be stripped and posteriorly based myomucosal flap was created containing palatal muscle and nasal mucosa. Nasal mucosa will be sutured followed by oral mucosa with minimal palatal muscle overlapping. The oral mucosa defect will be filled with BMMF Two flap palatoplasty surgical steps (group 2) A bilateral tongue like palatal flaps will be incised and elevated from the incisive foramen anteriorly to the hamulus posteriorly medial to the teeth and extended around the cleft area. Palatal muscles will be detached from the palatal shelves and separating it from the nsal mucosa. Nasal layer will be the firstly closed, followed by the muscle and oral mucosal layers. In case of the presence of a bare area of bone, it will be left to heal by secondary intention

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

9-12 months old childreen with complete cleft lip and palate, nonsyndromic.

lip and palate repair performed by one craniofacial surgeon

Disqualifiers

Patients with syndromic cleft lip.

Redu cases

Bilateral cleft lip

Associated Cardiac anomalies.

Trial design

Design model

Parallel

Treatments tested in this trial

  • furlow with buccinator

    Procedure/Surgery

    clefted patients were treated with furlow with buccinator flap

  • two flap palatoplasty

    Procedure/Surgery

    clefted patients were treated with two flap palatoplasty

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: furlow with buccinatorExperimental treatment 1 intervention
Group B: two flap palatoplastyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

fistula formation

assessment the fistula formation after cleft palate repair by determination the site of fistula and time at which appear

Time frame
6 months postoperative

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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