Repair of Oronasal Fistula Using Interpositional Buccal Pad of Fat as a Free Graft in a Cleft Palate Patient
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tanta University
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- evaluation of wound healing
Study Overview
Brief Summary
36 cleft palate patients had residual oronasal fistula included in this study divided randomly to two groups group I (control group): the fistula was repaired using two layers (oral and nasal layers) group II (study group): The fistula was repaired using two layers (oral and nasal layers ) with interpositional free buccal pad of fat graft between two layers
Detailed Description
36 cleft palate patients had residual oronasal fistula included in this study devided randomly to two groups group I (control group):the fistula was repaired using two layers nasal layer:closed by turn-in flaps, taken from around the margins of the fistula by making incision around margins of distance slightly larger than half of diameter of fistula bilaterally, then closed by inverted interrupted suture Vicry l 4/0.
oral layer:(Bardach two-flap palatoplasty) was used and raised on opposite sides of the cleft palate and brought together in the midline to create a continuous palate
group II (study group): The fistula was repaired using two layers (oral and nasal layers ) as group I with buccal pad of fat free graft was taken through veastibular incision at zygomatic buttress then blunt dissection to get buccal fat which was released from its pedicle and inserted between oral and nasal layers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 5 Years to 20 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •cleft palate patients with oro-nasal fistula fistula in hard palate
Exclusion Criteria
- •syndromatic patients
Arms & Interventions
repair of oro-nasal fistula using two layers
the fistula will be closed using two layers nasal layer by turning over the fistula margin and closure with 4/0 vicryl oral layer using two flap palatoplasty with relaxing incision around the alveolar margin and approximate at the midline using 4/0 vicryl
Intervention: closure of oro-nasal fistula in cleft palate patients (Procedure)
repair of oro-nasal fistula using two layers with interpositional buccal pad of fat free graft
the fistula will be closed using two layers nasal layer by turning over the fistula margin and closure with 4/0 vicryl oral layer using two flap palatoplasty with relaxing incision around the alveolar margin and approximate at the midline using 4/0 vicryl then a free graft of buccal pad of fat will be obtained and inserted between the two layers
Intervention: closure of oro-nasal fistula in cleft palate patients (Procedure)
Outcomes
Primary Outcomes
evaluation of wound healing
Time Frame: one month
five level 1. very poor 2. poor 3. good 4. very good 5. excellent
recurrence of oro-nasal fistula
Time Frame: one -3 months
present or abscent
Secondary Outcomes
- postoperative pain(one month)
Investigators
mona samy sheta
principle investigator
Tanta University