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

8 giugno 2026 aggiornato da: Gabriela Batista Holanda, Hospital Edmundo Vasconcelos

EFEITOS DO USO DE FIBRINA RICA EM PLAQUETAS NO PÓS-OPERATÓRIO DE CIRURGIAS NASOSSINUSAIS

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.

Panoramica dello studio

Descrizione dettagliata

## Methodology

This study was designed as a prospective, controlled, double-blind trial. Data were collected using a standardized clinical questionnaire completed by the attending physicians of patients undergoing sinonasal surgery at the Centro de Otorrinolaringologia e Fonoaudiologia de São Paulo (COF), São Paulo, Brazil. A specific data collection form was used to record postoperative clinical findings.

  • Study Procedures

    1. The study population consisted of patients undergoing sinonasal surgery at COF, who were evaluated at 1 week and 1 month postoperatively.
    2. Platelet-rich fibrin (PRF) was prepared intraoperatively through autologous blood collection followed by centrifugation in the operating room, requiring approximately 20 minutes.
    3. PRF membrane was randomly applied topically to one nasal cavity, while the contralateral cavity served as the control.
    4. At the end of the procedure, while the patient remained under general anesthesia, the PRF membrane was placed by the assisting surgeon without the presence of the attending surgeon in the operating room.
    5. Neither the attending surgeon responsible for postoperative evaluations nor the patient was aware of which nasal cavity had received PRF treatment.
    6. The questionnaire (Figure 1) was completed during routine postoperative visits at 1 week and 1 month following surgery, after otorhinolaryngological examination performed by the attending surgeon.
    7. The physician completed a separate evaluation form for each nasal cavity, allowing intra-patient comparison between treated and untreated sides.
    8. Confidentiality of patient records and questionnaire data was ensured through the signing of confidentiality and informed consent agreements by all participants.
    9. Collected data were organized in standardized databases. The study was conducted in accordance with the principles of the Declaration of Helsinki and Resolution No. 466/2012 of the Brazilian National Health Council regarding research involving human subjects.
    10. A database was created for each participant, including the following variables: descriptive nasal bleeding scale, descriptive crust formation scale, sex, age, and type of surgical procedure performed.
  • Inclusion Criteria

Patients undergoing sinonasal surgery at the Centro de Otorrinolaringologia e Fonoaudiologia de São Paulo (COF), São Paulo, Brazil, were eligible for inclusion.

Confidentiality of medical records and questionnaire data was ensured through the execution of confidentiality agreements between study participants and the institution.

### Exclusion Criteria

Patients who declined participation or failed to sign the informed consent form were excluded.

Patients who did not attend either the 1-week or 1-month postoperative follow-up visits were also excluded.

## Statistical Methodology

### Sample Characteristics

The initial sample consisted of 18 patients, including 8 women and 10 men, aged between 25 and 43 years.

During the study period, 4 patients were excluded because they failed to attend the scheduled postoperative visits at either 1 week or 1 month. Consequently, the final sample comprised 14 patients, including 7 women and 7 men.

All surgical procedures included partial inferior turbinectomy (100%).

### Statistical Analysis

Exploratory data analysis included calculation of means, medians, standard deviations, and ranges for continuous variables, as well as frequencies and proportions for categorical variables.

The distribution of numerical variables was assessed using descriptive statistics, histograms, boxplots, and the Shapiro-Wilk test for normality.

Comparative analyses of outcomes between postoperative time points (1 week and 1 month) and treatment groups (PRF-treated versus control side) were performed using Rank-Based Analysis of Variance (Rank ANOVA) as described by Wobbrock et al. (2011).

Partial eta squared (η²ₚ) was calculated as a measure of effect size for the overall ANOVA model and interpreted according to conventional thresholds:

  • η²ₚ = 0.01: small effect
  • η²ₚ = 0.06: medium effect
  • η²ₚ = 0.14: large effect

Tipo di studio

Interventistico

Iscrizione (Effettivo)

14

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • São Paulo
      • São Paulo, São Paulo, Brasile, 04038-905
        • Hospital Edmundo Vasconcelos

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Split-Nose PRF vs Control
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.
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.
No intervention done in one side of the nasal cavity
Comparatore placebo: Split Nose vs. Control
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.
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.
No intervention done in one side of the nasal cavity

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Postoperative Nasal Crusting Score
Lasso di tempo: From enrollment to the end of treatment at 4 weeks
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Postoperative Nasal Bleeding Score
Lasso di tempo: 1 week and 1 month after surgery
Comparison of postoperative nasal bleeding between PRF-treated and untreated nasal cavities following partial inferior turbinectomy. Bleeding severity was assessed using a physician-reported ordinal scale ranging from 1 (no bleeding) to 4 (severe bleeding requiring surgical intervention). Each patient served as their own control.
1 week and 1 month after surgery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Leonardo Bomediano Sousa Garcia

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 giugno 2024

Completamento primario (Effettivo)

1 settembre 2024

Completamento dello studio (Effettivo)

1 ottobre 2024

Date di iscrizione allo studio

Primo inviato

8 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 giugno 2026

Primo Inserito (Effettivo)

12 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 8229452400000090

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

ndividual participant data (IPD) will not be shared because the study was conducted as a single-center investigator-initiated trial with a limited sample size. No formal data-sharing infrastructure was established at the time of study conduct, and sharing of participant-level data could increase the risk of re-identification despite de-identification procedures.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Chirurgia dei turbinati

Prove cliniche su Platelet-rich fibrin (PRF)

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