Skip to content

Injectable Platelet Rich Fibrin Post Tonsillectomy

Effect of the Injectable Platelet Rich Fibrin After Tonsillectomy on Wound Healing Hemostasis and Post Operative Pain

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06304935
Enrollment
100
Registered
2024-03-12
Start date
2024-05-01
Completion date
2025-07-01
Last updated
2024-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IPRF Post Tonsillectomy

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. \[6-10\]

Interventions

OTHERUse 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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
IPRF effect on healingAssessment 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-operativeAssessment 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
IPRF effect on post tonsillectomy pain and bleedingAssessment 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 operativeCompare tested side and other control side by use of VAS score

Contacts

Primary ContactShaimaa Mohamed Awad Allah, Master
s6shimaamohamed96@gmail.com01156970082
Backup ContactAhmed Abu ELWAFA AbdulJaleel
ahmedshd1@aun.edu.eg01019729329

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026