NCT06996106

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 30, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

7 months

First QC Date

May 2, 2025

Last Update Submit

May 28, 2025

Conditions

Nasal Septum; DeviationNasal Septal Srur

Outcome Measures

Primary Outcomes (1)

  • 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

    postoperative at 1st week , 1st month , 3rd month

Study Arms (2)

platelet rich fibrin

ACTIVE COMPARATOR

usage of platelet rich fibrin in this arm underging setoplasty

Other: Effect of Platelet Rich Fibrin on Septoplasty

control group

ACTIVE COMPARATOR

traditional septoplasty

Other: Effect of Platelet Rich Fibrin on Septoplasty

Interventions

Effect of Platelet Rich Fibrin on SeptoplastyOTHER

it is a randomized trial of usage of platelet rich fibrin in septoplasty

control groupplatelet rich fibrin

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18-65 years undergoing septoplasty. Presence of cartilage deviated nasal septum requiring repair. No contraindications to PRF therapy.

You may not qualify if:

  • History of coagulopathy or anticoagulant therapy. Active infection or systemic disease. Known hypersensitivity to PRF components. Previous nasal surgery Autoimmune or systemic inflammatory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

‪Ahmed ibrahim‬, M.B.B. Ch, Otorhinolary

CONTACT

0201014848903ai731540@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ahmed ibrahim

Study Record Dates

First Submitted

May 2, 2025

First Posted

May 30, 2025

Study Start

June 1, 2025

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share