Injectable Platelet Rich Fibrin Post Tonsillectomy
- Conditions
- IPRF Post Tonsillectomy
- Interventions
- Other: Use of injectable platelet rich fibrin after tonsillectomy by injection of IPRF in one tonsillar bed and use of other side as control
- Registration Number
- NCT06304935
- Lead Sponsor
- Assiut University
- Brief Summary
To evaluate the effect of injectable Prf on healing, hemostasis and pain post tonsillectomy
- Detailed Description
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. \[6-10\]
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Any patient indicated for tonsillectomy who will undergo either tonsillectomy alone or adenotonsillectomy
- children who expected to be unreliable in expressing pain due to behavioural pattern or disorder, developmental delayed, age less than 5yrs
- residence outside the city or patient unable to come for follow-up.
- children who have high anaesthetic risk or uncontrolled medical illness.
- bleeding diathesis.
- acute infection.
- unilateral tonsillectomy.
- Hemoglobin level<10mg/dl
- positive viral markers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description One Group of pt used one tonsillar bed (tested) side other tonsillar bed (control) Use of injectable platelet rich fibrin after tonsillectomy by injection of IPRF in one tonsillar bed and use of other side as 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
- Primary Outcome Measures
Name Time Method IPRF effect on post tonsillectomy pain and bleeding Assessment of pain and bleeding post tonsillectomy in tested side in comparison with other side Which used as control in first day every 6 hr and then every 3 days to 15 day post operative Compare tested side and other control side by use of VAS score
IPRF effect on healing Assessment of healing post tonsillectomy in tested side in comparison with other side Which used as control in post tonsillectomy on 3rd day post operative and every 3 days to 15th day post-operative Assessment of healing on both sides of tonsillar beds post tonsillectomy one tested side (injectable platelet rich fibrin injected in) other control (IPRF not used) by assessment of pinkish membrane percent of the coverage on the tonsillar fossa comparing the tested site and control site at the 3rd, 6th, and every 3 days to 15th day post-operative and score will be calculated as if pinkish membrane percent of coverage on the tonsillar fossa less than 10% score 0, If pinkish membrane percent of coverage on 10_25%score1,when pinkish membrane percent of coverage on the tonsillar fossa 25_50%score2,If pinkish area more 50%score3
- Secondary Outcome Measures
Name Time Method