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

2026年6月8日 更新者: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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

## 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

研究の種類

介入

入学 (実際)

14

段階

  • フェーズ2
  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • São Paulo
      • São Paulo、São Paulo、ブラジル、04038-905
        • Hospital Edmundo Vasconcelos

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:非ランダム化
  • 介入モデル:並列代入
  • マスキング:ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的: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
プラセボコンパレーター: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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Postoperative Nasal Crusting Score
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Postoperative Nasal Bleeding Score
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディディレクター:Leonardo Bomediano Sousa Garcia

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年6月15日

一次修了 (実際)

2024年9月1日

研究の完了 (実際)

2024年10月1日

試験登録日

最初に提出

2026年6月8日

QC基準を満たした最初の提出物

2026年6月8日

最初の投稿 (実際)

2026年6月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月12日

QC基準を満たした最後の更新が送信されました

2026年6月8日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 8229452400000090

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

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.

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いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

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