Does the plasma-rich growth factor (PRGF) with primary cleft palate repair accelerate wound healing and prevent post-operative oronasal fistula occurrence?
The primary objective is to assess and evaluate the improvement of wound healing (edema at 5th day post operatively) as a primary outcome, and secondary objective is to assess and evaluate the wound closure and the decreasing of the occurrence of the oronasal fistula as a secondary outcome among children with cleft palate, using plasma rich growth factor between nasal mucosa and palatal mucosa
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
using prgf with closing primary cleft palate - isolated cleft palate Minutes before the surgery, 10-20 ml of venous blood from each patient. -The blood is centrifuged to obtain PRGF. -Fixed between nasal and palatal mucosa
primary closing cleft palate-isolated cleft palate
Faculty of Dentistry, Cairo University
Manial, Cairo Governorate, Egypt
wound healing assesment (edema at 5th day post operatively)
clinical records, percentage of persistence of edema number of participants with percentage of persisting of edema
Time frame: first day after surgery, 3rd day, and 5th day
wound healing assesment
clinical records, counting days for healing as healing by days till closure
Time frame: 2 years
the occurrence of oronasal fistula
clinical records, yes/no Postoperative complications; mainly oronasal fistula by; clinical observation: inspection, clinical signs: regurgitation of food or drink
Time frame: first day after surgery to end of treatment at 3 months
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