Role of Plasma Rich Growth Factor in Repair Primary Cleft Palate (PRGF)

Cairo University (CU)

Status: Not yet enrolling

Conditions: Plasma Rich in Growth Factors; Cleft Palate

Treatments: Other: Placebo; Other: Plasma Rich in Growth Factors (PRGF)

Study type: Interventional

Funder types: Other

Identifiers

NCT06889181

Cleft palate - Omfs338

Details and patient eligibility

About

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

Full 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

Enrollment: 36 estimated patients

Sex: All

Ages: 6 to 18 months old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups, including a placebo group

plasma rich growth factor (PRGF) (intervention or study group)

Active Comparator group

Description:

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

Treatment:

Other: Plasma Rich in Growth Factors (PRGF)

placebo (control group)

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo