Effects of Platelet-Rich Fibrin on Postoperative Outcomes Following Nasosinusal Surgery

NCT07645053 | Completed Phase 1

• 1 other identifier: 8229452400000090
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

tudy Design This was a prospective, randomized, double-blind, controlled clinical trial designed to evaluate the effects of platelet-rich fibrin (PRF) on postoperative healing following partial inferior turbinectomy. Patients undergoing surgery at the Centro de Otorrinolaringologia e Fonoaudiologia de São Paulo (COF) were allocated to either a PRF treatment group or a control group. Postoperative outcomes were assessed at 1 week and 1 month after surgery using a standardized evaluation protocol completed by blinded investigators. Clinical parameters related to wound healing and postoperative recovery were recorded and subsequently compared between groups to determine the impact of PRF application on surgical outcomes.

Conditions

Turbinate Surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative Nasal Crusting Score

  Comparison of postoperative nasal crust formation between PRF-treated and untreated nasal cavities following partial inferior turbinectomy. Crusting severity was assessed using a physician-reported ordinal scale ranging from 1 (no crusting) to 4 (severe crusting). Each patient served as their own control, with one nasal cavity randomly assigned to receive topical platelet-rich fibrin (PRF) and the contralateral cavity serving as an untreated control.

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (1)

• Postoperative Nasal Bleeding Score

  1 week and 1 month after surgery

Study Arms (2)

Split-Nose PRF vs Control

EXPERIMENTAL

Each participant served as their own control. Following partial inferior turbinectomy, platelet-rich fibrin (PRF) membrane was randomly applied to one nasal cavity, while the contralateral nasal cavity received no PRF treatment. Postoperative outcomes, including nasal crusting and bleeding, were evaluated at 1 week and 1 month after surgery by blinded assessors.

Procedure: Platelet-rich fibrin (PRF); Procedure: Control

Split Nose vs. Control

PLACEBO COMPARATOR

Each participant served as their own control. Following partial inferior turbinectomy, platelet-rich fibrin (PRF) membrane was randomly applied to one nasal cavity, while the contralateral nasal cavity received no PRF treatment. Postoperative outcomes, including nasal crusting and bleeding, were evaluated at 1 week and 1 month after surgery by blinded assessors.

Procedure: Platelet-rich fibrin (PRF); Procedure: Control

Interventions

Platelet-rich fibrin (PRF) PROCEDURE

Autologous platelet-rich fibrin (PRF) prepared intraoperatively from the participant's peripheral blood through a single-step centrifugation process. The resulting fibrin membrane was applied topically to one randomly selected nasal cavity at the completion of partial inferior turbinectomy, while the contralateral nasal cavity served as an untreated control. PRF contains a dense fibrin matrix enriched with platelets, leukocytes, cytokines, and growth factors that may promote mucosal healing and reduce postoperative crust formation. Postoperative outcomes were assessed at 1 week and 1 month after surgery by blinded evaluators.

Split Nose vs. Control; Split-Nose PRF vs Control

Control PROCEDURE

No intervention done in one side of the nasal cavity

Split Nose vs. Control; Split-Nose PRF vs Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older. Patients undergoing sinonasal surgery including partial inferior turbinectomy at the Centro de Otorrinolaringologia e Fonoaudiologia de São Paulo (COF).
• Ability to provide written informed consent. Willingness to attend scheduled postoperative follow-up visits at 1 week and 1 month after surgery.

You may not qualify if:

• Refusal or inability to provide written informed consent. Failure to attend either the 1-week or the 1-month postoperative follow-up visit.
• Incomplete postoperative evaluation data.

Sponsors & Collaborators

• Hospital Edmundo Vasconcelos: lead

Study Sites (1)

Hospital Edmundo Vasconcelos

São Paulo, São Paulo, 04038-905, Brazil

Location

Related Publications (12)

• Qin X, Sun Q, Chen G, Liu J, Gao T, Bai G, Guo Z. Risk factors for postoperative bleeding after endoscopic sinus surgery to treat chronic rhinosinusitis. Acta Otolaryngol. 2021 Apr;141(4):392-396. doi: 10.1080/00016489.2021.1878276. Epub 2021 Feb 13.

  PMID: 33586594 BACKGROUND

• Sharifi A, Kouhi A, Patel ZM. Utilization and efficacy of platelet-rich plasma and platelet-rich fibrin in otolaryngology: a systematic evidence-based review. Eur Arch Otorhinolaryngol. 2024 Oct;281(10):5091-5110. doi: 10.1007/s00405-024-08763-1. Epub 2024 Jun 24.

  PMID: 38914822 BACKGROUND

• Dinaki K, Grigoriadis N, Papadopoulos C, Vizirianakis I, Constantinidis J, Triaridis S, Karkos P. Platelet-Rich Fibrin in Otorhinolaryngology. Maedica (Bucur). 2023 Dec;18(4):672-678. doi: 10.26574/maedica.2023.18.4.672.

  PMID: 38348084 BACKGROUND

• 9. Vendramin FS, Franco D, Nogueira CM, Pereira MS, Franco TR. Plasma rico em plaquetas e fatores de crescimento: técina de preparo e utilização em cirurgia plástica. Ver. Col. Bras. Cir. 33(1); Fev, 2006.

  BACKGROUND

• 8. Choukroun J, Adda F, Schoeffler C, Vervelle A. [An opportunity in paroimplantology: PRF.] Implantodontie. 2001;42(55):e62.

  BACKGROUND

• Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part IV: clinical effects on tissue healing. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e56-60. doi: 10.1016/j.tripleo.2005.07.011.

  PMID: 16504852 BACKGROUND

• Fioravanti C, Frustaci I, Armellin E, Condo R, Arcuri C, Cerroni L. Autologous blood preparations rich in platelets, fibrin and growth factors. Oral Implantol (Rome). 2016 Jul 23;8(4):96-113. doi: 10.11138/orl/2015.8.4.096. eCollection 2015 Oct-Dec.

  PMID: 28042422 BACKGROUND

• 5. Vieira, Fernando Mirage Jardim, et al. "Platelet Rich Fibrin (PRF): An Autologous Biomaterial for Turbinectomy Healing Assistance." American Journal of Otolaryngology and Head and Neck Surgery 6.1 (2018): 2-3.

  BACKGROUND

• Lei X, Cheng L, Yang Y, Pang M, Dong Y, Zhu X, Chen C, Yao Z, Wu G, Cheng B, Forouzanfar T. Co-administration of platelet-rich plasma and small intestinal submucosa is more beneficial than their individual use in promoting acute skin wound healing. Burns Trauma. 2021 Nov 30;9:tkab033. doi: 10.1093/burnst/tkab033. eCollection 2021.

  PMID: 35464804 BACKGROUND

• 3. Aboelnaga, Heba Abdelreheem, et al. "Evaluation of the use of autologous platelet-rich fibrin in myringoplasty operation." The Egyptian Journal of Otolaryngology 38.1 (2022): 142.

  BACKGROUND

• 2. Tratado de otorrinolaringologia / organizacao Shirley Shizue Nagata Pignatari, Wilma Terezinha Anselmo- Lima. 3. ed. Rio de Janeiro: Elsevier, 2018

  BACKGROUND

• 1. Balsalobre L, Tepedino MS. Rinologia 360º: Aspectos Clínicos e Cirúrgicos. Thieme Revinter; Brasil, 2021

  BACKGROUND

Study Officials

• Leonardo Bomediano Sousa Garcia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and postoperative evaluators were blinded to treatment allocation. At the completion of surgery, an assisting surgeon applied the platelet-rich fibrin (PRF) membrane to one randomly selected nasal cavity while the attending surgeon responsible for postoperative assessments was absent from the operating room. During follow-up visits at 1 week and 1 month, evaluators were unaware of which nasal cavity had received PRF treatment. Patients were also blinded to treatment allocation throughout the study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start: June 15, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

BR (1)