IPRF Post TonsillectomyNCT06304935
Injectable Platelet Rich Fibrin Post Tonsillectomy
A study of IPRF Post Tonsillectomy, run by Assiut University.
Trial summary
To evaluate the effect of injectable Prf on healing, hemostasis and pain post tonsillectomy Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- IPRF Post Tonsillectomy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any patient indicated for tonsillectomy who will undergo either tonsillectomy alone or adenotonsillectomy
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of the Injectable Platelet Rich Fibrin After Tonsillectomy on Wound Healing Hemostasis and Post Operative Pain
To evaluate the effect of injectable Prf on healing, hemostasis and pain post tonsillectomy
Read the 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]
- Conditions
- IPRF Post Tonsillectomy
- Being tested
- Use of injectable platelet rich fibrin after tonsillectomy by injection of IPRF in one tonsillar bed and use of other side as control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of injectable platelet rich fibrin after tonsillectomy by injection of IPRF in one tonsillar bed and use of other side as controlOther
Compare both sides of tonsillar beds in post operative healing, pain and hemostasis
| Study group | Role | What they receive |
|---|---|---|
| One Group of pt used one tonsillar bed (tested) side other tonsillar bed (control) | Other | 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 Receives: Other: Use of injectable platelet rich fibrin after tonsillectomy by injection of IPRF in one tonsillar bed and use of other side as control |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPRF effect on healing
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
Measured: 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
IPRF effect on post tonsillectomy pain and bleeding
Compare tested side and other control side by use of VAS score
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for IPRF Post TonsillectomyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohamed Awad Allah, Assiut University
- Investigators
- Ahmed Gamal Sholkamy, Lecturer, Study director, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304935
- Sponsor's protocol ID
- IPRF effect post tonsillectomy
- Status last verified
- Apr 2024
- First submitted
- 5 Mar 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28154995Alexander 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.
PubMed 5857215Harley 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.
PubMed 9807075
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Injectable Platelet Rich Fibrin After Tonsillectomy on Wound Healing Hemostasis and Post Operative Pain
- ClinicalTrials.gov ID
- NCT06304935
- Acronym / sponsor ID
- IPRF effect post tonsillectomy
- Conditions
- IPRF Post Tonsillectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One Group of pt used one tonsillar bed (tested) side other tonsillar bed (control) | Other | Other: Use of injectable platelet rich fibrin after tonsillectomy by injection of IPRF in one tonsillar bed and use of other side as controlIn 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 |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient indicated for tonsillectomy who will undergo either tonsillectomy alone or adenotonsillectomy
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of injectable platelet rich fibrin after tonsillectomy by injection of IPRF in one tonsillar bed and use of other side as controlCompare both sides of tonsillar beds in post operative healing, pain and hemostasis | Other | One Group of pt used one tonsillar bed (tested) side other tonsillar bed (control) |
Primary outcome
IPRF effect on healing
Time frame: 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
IPRF effect on post tonsillectomy pain and bleeding
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Background: PubMed 28154995Miron 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.
- Results publication: PubMed 5857215Alexander 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.
- Results publication: PubMed 9807075Harley 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Gamal Sholkamy, Lecturer study director
Lecturer
Questions about this trial
What is this clinical trial studying?
A study of IPRF Post Tonsillectomy, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaimaa Mohamed Awad Allah, Master (01156970082, s6shimaamohamed96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IPRF effect on healing (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06304935, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024; AzTrials last refreshed its copy on 30 Oct 2026.