Role of Plasma Rich Growth Factor in Repair Primary Cleft Palate

NCT06889181 — Not applicable, Not yet recruiting, 36 participants, Cairo University

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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

Registry	NCT06889181, acronym PRGF
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	36 (Estimated)
Sponsor	Cairo University (Other)
Conditions	Cleft Palate, Plasma Rich in Growth Factors
Interventions	Plasma Rich in Growth Factors (PRGF), Placebo (Other)
Dates	start 2025-04-01 (estimated), primary completion 2025-07-30 (estimated), completion 2027-06-30 (estimated), first posted 2025-03-21, last updated 2025-03-21
Locations	1 site in Egypt

-Summary

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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+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

+Arms and interventions

Arm	Type	Interventions	Description
plasma rich growth factor (PRGF) (intervention or study group)	Active comparator	Other: Plasma Rich in Growth Factors (PRGF)	plasma rich growth factor (PRGF) intervention or study group Has Surgical procedures "von Langenbeck technique " to repair cleft palate and placing plasma rich growth factors between nasal and palatal tissue then primary closure intraoperatively, then patient will come for follow up visit after surgery, 1st day, 3rd, 5th day and come for follow up visits at 1 week, 1 month and 3 months postoperative
placebo (control group)	Placebo comparator	Other: Placebo	placebo (control group) Has Surgical procedures "von Langenbeck technique " to repair cleft palate primary closure, then patient will come for follow up visit after surgery, 1st day, 3rd, 5th day and come for follow up visits at 1 week, 1 month and 3 months postoperative

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

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 6 Months to 18 Months, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Faculty of Dentistry, Cairo University	Manial, Cairo Governorate	Egypt