Nasal Septum; DeviationNCT06996106
Outcomes of PRF on Septoplasty in Patient With Nasal Septal Deviation
A study testing Effect of Platelet Rich Fibrin on Septoplasty in people with Nasal Septum; Deviation and Nasal Septal Srur, run by Kafrelsheikh University.
Trial summary
The aim of this study is to assess the effectiveness of Platelet-Rich Fibrin (PRF) in improving postoperative healing, reducing complications, and enhancing functional outcomes in patients undergoing septoplasty Read more about this study
- Who is it for?
- Ages Up to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Septum; Deviation, Nasal Septal Srur
- What is being tested?
- Effect of Platelet Rich Fibrin on Septoplasty
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adults aged 18-65 years undergoing septoplasty. Presence of cartilage deviated nasal septum requiring repair. No contraindications to PRF therapy.
Who cannot join
- History of coagulopathy or anticoagulant therapy. Active infection or systemic disease. Known hypersensitivity to PRF components. Previous nasal surgery Autoimmune or systemic inflammatory disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Platelet Rich Fibrin on Septoplasty :A Comparative Study
The aim of this study is to assess the effectiveness of Platelet-Rich Fibrin (PRF) in improving postoperative healing, reducing complications, and enhancing functional outcomes in patients undergoing septoplasty
Read the detailed description
Septoplasty is a routine surgical intervention to correct nasal septal deviation, a major cause of nasal obstruction and chronic sinusitis. Despite advancements, postoperative complications-such as mucosal injury, synechiae, septal perforation, and hematoma-continue to impact outcomes and patient satisfaction.
Platelet-rich fibrin (PRF), first described by Choukroun et al., represents an autologous biomaterial rich in growth factors like PDGF, TGF-β, VEGF, and IGF-1, known to accelerate wound healing and tissue regeneration. Unlike platelet-rich plasma (PRP), PRF is easier to prepare, does not require anticoagulants, and forms a fibrin matrix conducive to sustained release of cytokines.
Several studies across disciplines-oral surgery, dermatology, orthopedics-support the regenerative potential of PRF. In nasal surgery, the delicate mucosal environment could benefit significantly from enhanced healing facilitated by PRF.
- Conditions
- Nasal Septum; Deviation, Nasal Septal Srur
- Being tested
- Effect of Platelet Rich Fibrin on Septoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of Platelet Rich Fibrin on SeptoplastyOther
it is a randomized trial of usage of platelet rich fibrin in septoplasty
| Study group | Role | What they receive |
|---|---|---|
| platelet rich fibrin | Active comparator | usage of platelet rich fibrin in this arm underging setoplasty Receives: Other: Effect of Platelet Rich Fibrin on Septoplasty |
| control group | Active comparator | traditional septoplasty Receives: Other: Effect of Platelet Rich Fibrin on Septoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of submucoperichondrial application of platelet rich fibrin on healing of nasal septum mucosa after septoplasty
Mucosal Healing will be assessed by visual nasal endscope
Measured: postoperative at 1st week , 1st month , 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study startJun 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Septum; DeviationStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ibrahim Abdallah Abdel wahd Abo Hussein, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996106
- Sponsor's protocol ID
- PRF in septoplasty
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Platelet Rich Fibrin on Septoplasty :A Comparative Study
- ClinicalTrials.gov ID
- NCT06996106
- Acronym / sponsor ID
- PRF in septoplasty
- Conditions
- Nasal Septum; Deviation, Nasal Septal Srur
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 30 May 2025 (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.
The aim of this study is to assess the effectiveness of Platelet-Rich Fibrin (PRF) in improving postoperative healing, reducing complications, and enhancing functional outcomes in patients undergoing septoplasty
Detailed description
Septoplasty is a routine surgical intervention to correct nasal septal deviation, a major cause of nasal obstruction and chronic sinusitis. Despite advancements, postoperative complications-such as mucosal injury, synechiae, septal perforation, and hematoma-continue to impact outcomes and patient satisfaction.
Platelet-rich fibrin (PRF), first described by Choukroun et al., represents an autologous biomaterial rich in growth factors like PDGF, TGF-β, VEGF, and IGF-1, known to accelerate wound healing and tissue regeneration. Unlike platelet-rich plasma (PRP), PRF is easier to prepare, does not require anticoagulants, and forms a fibrin matrix conducive to sustained release of cytokines.
Several studies across disciplines-oral surgery, dermatology, orthopedics-support the regenerative potential of PRF. In nasal surgery, the delicate mucosal environment could benefit significantly from enhanced healing facilitated by PRF.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| platelet rich fibrin | Active comparator | Other: Effect of Platelet Rich Fibrin on Septoplastyusage of platelet rich fibrin in this arm underging setoplasty |
| control group | Active comparator | Other: Effect of Platelet Rich Fibrin on Septoplastytraditional septoplasty |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18-65 years undergoing septoplasty. Presence of cartilage deviated nasal septum requiring repair. No contraindications to PRF therapy.
Key exclusion criteria (1 listed)
- History of coagulopathy or anticoagulant therapy. Active infection or systemic disease. Known hypersensitivity to PRF components. Previous nasal surgery Autoimmune or systemic inflammatory disease
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 |
|---|---|---|
| Effect of Platelet Rich Fibrin on Septoplastyit is a randomized trial of usage of platelet rich fibrin in septoplasty | Other | control group, platelet rich fibrin |
Primary outcome
Effect of submucoperichondrial application of platelet rich fibrin on healing of nasal septum mucosa after septoplasty
Time frame: postoperative at 1st week , 1st month , 3rd month
Mucosal Healing will be assessed by visual nasal endscope
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Effect of Platelet Rich Fibrin on Septoplasty in people with Nasal Septum; Deviation and Nasal Septal Srur, run by Kafrelsheikh 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 1 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: opening soon, as of the sponsor's last update on 30 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed ibrahim, M.B.B. Ch, Otorhinolary (0201014848903, ai731540@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of submucoperichondrial application of platelet rich fibrin on healing of nasal septum mucosa after septoplasty (time frame: postoperative at 1st week , 1st month , 3rd month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2025.