Turbinate SurgeryPhase 1/2NCT07645053
Effects of Platelet-Rich Fibrin on Postoperative Outcomes Following Nasosinusal Surgery
A Phase 1/2 study testing Platelet-rich fibrin (PRF) in people with Turbinate Surgery, run by Hospital Edmundo Vasconcelos at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Turbinate Surgery
- What is being tested?
- Platelet-rich fibrin (PRF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Jun 2024to 1 Oct 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
## 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
- Conditions
- Turbinate Surgery
- Being tested
- Platelet-rich fibrin (PRF), Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich fibrin (PRF)Procedure or surgery
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.
ControlProcedure or surgery
No intervention done in one side of the nasal cavity
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Platelet-rich fibrin (PRF); Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (1)
Postoperative Nasal Bleeding Score
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.
Measured: 1 week and 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start15 Jun 2024
- Primary completion1 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Turbinate SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Edmundo Vasconcelos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela Batista Holanda, Hospital Edmundo Vasconcelos
- Investigators
- Leonardo Bomediano Sousa Garcia, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645053
- Sponsor's protocol ID
- 8229452400000090
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 33586594Sharifi 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.
PubMed 38914822Dinaki 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.
PubMed 383480849. 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.
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.
PubMed 16504852Fioravanti 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.
PubMed 280424225. 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.
PubMed 354648043. 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFEITOS DO USO DE FIBRINA RICA EM PLAQUETAS NO PÓS-OPERATÓRIO DE CIRURGIAS NASOSSINUSAIS
- ClinicalTrials.gov ID
- NCT07645053
- Acronym / sponsor ID
- 8229452400000090
- Conditions
- Turbinate Surgery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hospital Edmundo VasconcelosUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
## 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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Split-Nose PRF vs Control | Experimental | Procedure: Platelet-rich fibrin (PRF), Procedure: ControlEach 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. |
| Split Nose vs. Control | Placebo comparator | Procedure: Platelet-rich fibrin (PRF), Procedure: ControlEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet-rich fibrin (PRF)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. | Procedure or surgery | Split Nose vs. Control, Split-Nose PRF vs Control |
| ControlNo intervention done in one side of the nasal cavity | Procedure or surgery | Split Nose vs. Control, Split-Nose PRF vs Control |
Primary outcome
Postoperative Nasal Crusting Score
Time frame: 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.
1 secondary outcome
Postoperative Nasal Bleeding Score
Time frame: 1 week and 1 month after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Background: PubMed 33586594Qin 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.
- Background: PubMed 38914822Sharifi 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.
- Background: PubMed 38348084Dinaki 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.
- Background9. 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.
- Background8. Choukroun J, Adda F, Schoeffler C, Vervelle A. [An opportunity in paroimplantology: PRF.] Implantodontie. 2001;42(55):e62.
- Background: PubMed 16504852Choukroun 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.
- Background: PubMed 28042422Fioravanti 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.
- Background5. 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: PubMed 35464804Lei 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.
- Background3. 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.
- Background2. Tratado de otorrinolaringologia / organizacao Shirley Shizue Nagata Pignatari, Wilma Terezinha Anselmo- Lima. 3. ed. Rio de Janeiro: Elsevier, 2018
- Background1. Balsalobre L, Tepedino MS. Rinologia 360º: Aspectos Clínicos e Cirúrgicos. Thieme Revinter; Brasil, 2021
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonardo Bomediano Sousa Garcia study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Platelet-rich fibrin (PRF) in people with Turbinate Surgery, run by Hospital Edmundo Vasconcelos at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Nasal Crusting Score (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07645053, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.