Clinical trial NCT06304935: Injectable Platelet Rich Fibrin Post Tonsillectomy
Official title: Effect of the Injectable Platelet Rich Fibrin After Tonsillectomy on Wound Healing Hemostasis and Post Operative Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: IPRF Post Tonsillectomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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. \[6-10\]

Eligibility criteria: 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

Primary outcomes:
measure: IPRF effect on healing
timeFrame: 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
measure: IPRF effect on post tonsillectomy pain and bleeding
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Lecturer
name: Ahmed Gamal Sholkamy, Lecturer
role: STUDY_DIRECTOR
References:
citation: Miron RJ, Fujioka-Kobayashi M, Hernandez M, Kandalam U, Zhang Y, Ghanaati S, Choukroun J. Injectable platelet rich fibrin (i-PRF): opportunities in regenerative dentistry? Clin Oral Investig. 2017 Nov;21(8):2619-2627. doi: 10.1007/s00784-017-2063-9. Epub 2017 Feb 2.
citation: Alexander DW, Graff TD, Kelley E. Factors in tonsillectomy mortality. Arch Otolaryngol. 1965 Oct;82(4):409-11. doi: 10.1001/archotol.1965.00760010411015. No abstract available.
citation: Harley EH, Dattolo RA. Ibuprofen for tonsillectomy pain in children: efficacy and complications. Otolaryngol Head Neck Surg. 1998 Nov;119(5):492-6. doi: 10.1016/S0194-5998(98)70107-X.