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NCT Number: NCT06889181

Role of Plasma Rich Growth Factor in Repair Primary Cleft Palate

Does the plasma-rich growth factor (PRGF) with primary cleft palate repair accelerate wound healing and prevent post-operative oronasal fistula occurrence?

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Key information

Conditions

Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Plasma Rich in Growth Factors Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

6 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plasma Rich in Growth Factors (PRGF)

Other

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

Placebo

Other

primary closing cleft palate-isolated cleft palate

Primary outcomes

  1. wound healing assesment (edema at 5th day post operatively)

    Time frame: 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 outcomes

  1. wound healing assesment

    Time frame: 2 years

    clinical records, counting days for healing as healing by days till closure

  2. the occurrence of oronasal fistula

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Acronym: PRGF

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Mar 21, 2025
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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