- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07645053
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
## 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
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 2
- Faza 1
Kontakty i lokalizacje
Lokalizacje studiów
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São Paulo
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São Paulo, São Paulo, Brazylia, 04038-905
- Hospital Edmundo Vasconcelos
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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
|
|
Komparator 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
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Postoperative Nasal Crusting Score
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Postoperative Nasal Bleeding Score
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Leonardo Bomediano Sousa Garcia
Publikacje i pomocne linki
Publikacje ogólne
- 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
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- 8229452400000090
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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Badania kliniczne na Chirurgia małżowin
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University Hospital TuebingenRobert Bosch-Krankenhaus StuttgartRekrutacyjny
Badania kliniczne na Platelet-rich fibrin (PRF)
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Al-Mustansiriyah UniversityAktywny, nie rekrutującyZapalenie ozębnej | Utrata kości wyrostka zębodołowego | Kieszonka przyzębiaIrak
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Maharishi Markendeswar University (Deemed to be...ZakończonyUtrata kości | Przewlekłe zapalenie przyzębia | Wada przyzębia śródkostnegoIndie