Effects of Platelet-Rich Fibrin on Postoperative Outcomes Following Nasosinusal Surgery
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
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
- The study population consisted of patients undergoing sinonasal surgery at COF, who were evaluated at 1 week and 1 month postoperatively.
- Platelet-rich fibrin (PRF) was prepared intraoperatively through autologous blood collection followed by centrifugation in the operating room, requiring approximately 20 minutes.
- PRF membrane was randomly applied topically to one nasal cavity, while the contralateral cavity served as the control.
- 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.
- Neither the attending surgeon responsible for postoperative evaluations nor the patient was aware of which nasal cavity had received PRF treatment.
- 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.
- The physician completed a separate evaluation form for each nasal cavity, allowing intra-patient comparison between treated and untreated sides.
- Confidentiality of patient records and questionnaire data was ensured through the signing of confidentiality and informed consent agreements by all participants.
- 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.
- 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
入学 (実際)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
-
-
São Paulo
-
São Paulo、São Paulo、ブラジル、04038-905
- Hospital Edmundo Vasconcelos
-
-
参加基準
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
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
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
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
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
- 8. Choukroun J, Adda F, Schoeffler C, Vervelle A. [An opportunity in paroimplantology: PRF.] Implantodontie. 2001;42(55):e62.
- 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.
- 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.
- 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.
- 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.
- 2. Tratado de otorrinolaringologia / organizacao Shirley Shizue Nagata Pignatari, Wilma Terezinha Anselmo- Lima. 3. ed. Rio de Janeiro: Elsevier, 2018
- 1. Balsalobre L, Tepedino MS. Rinologia 360º: Aspectos Clínicos e Cirúrgicos. Thieme Revinter; Brasil, 2021
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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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?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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