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Not yet recruiting NCT06889181

Role of Plasma Rich Growth Factor in Repair Primary Cleft Palate

No phase Interventional Cleft Palate Plasma Rich in Growth Factors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Plasma Rich in Growth Factors (PRGF), Placebo.
Who it may be relevant to
Registry conditions: Cleft Palate, Plasma Rich in Growth Factors. Basic parameters: 6 months — 18 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Evaluation of the Role of the Plasma-rich Growth Factor (PRGF) with Primary Cleft Palate Repair Versus Primary Cleft Palate Repair in Post-operative Wound Healing and Oronasal Fistula Occurrence, a Randomized Clinical Trial

Overview

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

  • Other Plasma Rich in Growth Factors (PRGF)
    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
  • Other Placebo
    primary closing cleft palate-isolated cleft palate

Primary outcome measures

  • wound healing assesment (edema at 5th day post operatively) [Time frame: first day after surgery, 3rd day, and 5th day]
Secondary outcome measures (2)
  • wound healing assesment [Time frame: 2 years]
  • the occurrence of oronasal fistula [Time frame: first day after surgery to end of treatment at 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Dentistry, Cairo University — Manial

Identifiers

NCT: NCT06889181 · Cleft palate - Omfs338

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗