Injectable Platelet Rich Fibrin Post Tonsillectomy

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-07-01

Brief Summary

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To evaluate the effect of injectable Prf on healing, hemostasis and pain post tonsillectomy

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Detailed Description

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Tonsillectomy is the most common surgical procedure performed by otolaryngologists with or without adenoidectomy. \[1\] The most important complication of tonsillectomy is post-tonsillectomy hemorrhage with potential morbidity and death. \[2\] Also, severe pain and wound healing remain major problems that affect patients profoundly after surgery causing a lot of time to return to a regular diet and normal activity. \[3\] Pharmacological drugs are used to control post-tonsillectomy pain but with challenges like insufficiency to control pain, the presence of contraindications, and the presence of side effects as the antiplatelet effects of NSAIDs lead to increased rates of postoperative hemorrhage.\[4\] Growth factors and other mediators released by activated platelets play an important role in tissue regeneration and revascularization. Platelet concentrates, therefore, represent a promising therapeutic tool for tissue regeneration. In recent years, the effects of platelet-rich fibrin (PRF) on tissue healing have been addressed in many surgical branches, especially for dental implant surgery and plastic surgery.\[5\] Injectable platelet-rich fibrin (IPRF) is a recently developed leukocyte-enriched platelet concentrate, which could better assist tissue regeneration and wound healing phenomena. Although initially in a liquid phase, IPRF forms a dynamic fibrin gel embedding platelets, leukocytes, type 1 collagen (COL1), osteocalcin (OC), growth factors, and providing a slow release of growth factors. \[6-10\]

Conditions

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IPRF Post Tonsillectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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One Group of pt used one tonsillar bed (tested) side other tonsillar bed (control)

In the same Group one of tonsillar bed randamly injected with injectable platelet rich fibrin and other side as control and compare in post tonsillectomy healing, pain and hemostasis

Group Type OTHER

Use of injectable platelet rich fibrin after tonsillectomy by injection of IPRF in one tonsillar bed and use of other side as control

Intervention Type OTHER

Compare both sides of tonsillar beds in post operative healing, pain and hemostasis

Interventions

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Use of injectable platelet rich fibrin after tonsillectomy by injection of IPRF in one tonsillar bed and use of other side as control

Compare both sides of tonsillar beds in post operative healing, pain and hemostasis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- Any patient indicated for tonsillectomy who will undergo either tonsillectomy alone or adenotonsillectomy

Exclusion Criteria

1. children who expected to be unreliable in expressing pain due to behavioural pattern or disorder, developmental delayed, age less than 5yrs
2. residence outside the city or patient unable to come for follow-up.
3. children who have high anaesthetic risk or uncontrolled medical illness.
4. bleeding diathesis.
5. acute infection.
6. unilateral tonsillectomy.
7. Hemoglobin level\<10mg/dl
8. positive viral markers

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No