Role of Plasma Rich Growth Factor in Repair Primary Cleft Palate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2027-06-30

Brief Summary

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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

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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

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Cleft Palate Plasma Rich in Growth Factors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to either control or study group in the ratio of 1:1 using random number table.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Single blinded study. Blinding to the patient will be ensured by masking the instruments during the follow up. The patient will be informed of the steps of the follow up (as mentioned in the consent form) without getting into details of the method of follow up.

Study Groups

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

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

Group Type ACTIVE_COMPARATOR

Plasma Rich in Growth Factors (PRGF)

Intervention Type 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 (control group)

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

primary closing cleft palate-isolated cleft palate

Interventions

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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

Intervention Type OTHER

Placebo

primary closing cleft palate-isolated cleft palate

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes