Cleft Palate, Plasma Rich in Growth Factors
Conditions
Keywords
cleft palate, plasma rich growth factor, healing
Brief summary
Does the plasma-rich growth factor (PRGF) with primary cleft palate repair accelerate wound healing and prevent post-operative oronasal fistula occurrence?
Detailed description
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
Interventions
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
OTHERPlacebo
primary closing cleft palate-isolated cleft palate
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single blinded study. Blinding to the patient will be ensured by masking the instruments during the follow up. The patient will be informed of the steps of the follow up (as mentioned in the consent form) without getting into details of the method of follow up.
Intervention model description
Participants will be randomly assigned to either control or study group in the ratio of 1:1 using random number table.
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Months
Healthy volunteers
Yes
Inclusion criteria
* systemically healthy patients (American Society of Anesthesiologists -ASA I and II); not older than 6-18 months * Patients with primary non-syndromic isolated cleft palate * Apprehensive to be in the study.
Exclusion criteria
* Patients with recurrent palatal fistula * Existence of syndromic cleft palate * Blood diseases and platelet disorders (hematological disease) * Systematic disease radiotherapy or chemotherapy for malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| wound healing assesment (edema at 5th day post operatively) | first day after surgery, 3rd day, and 5th day | clinical records, percentage of persistence of edema number of participants with percentage of persisting of edema |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| wound healing assesment | 2 years | clinical records, counting days for healing as healing by days till closure |
| the occurrence of oronasal fistula | first day after surgery to end of treatment at 3 months | clinical records, yes/no Postoperative complications; mainly oronasal fistula by; clinical observation: inspection, clinical signs: regurgitation of food or drink |
Countries
Egypt
Outcome results
None listed