NCT06889181

Role of Plasma Rich Growth Factor in Repair Primary Cleft Palate

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 6 Months – 18 Months
• Healthy volunteers: Accepted

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

Conditions

• Cleft Palate
• Plasma Rich in Growth Factors

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-07-30
• Completion: 2027-06-30
• First posted: 2025-03-21
• Last updated: 2025-03-21

Locations

1 site across 1 country: Egypt