Benign Vocal Fold LesionsNCT07300800
Effect of PRP Injection on Voice Recovery After Benign Vocal Fold Surgery
A study testing Platelet-Rich Plasma (PRP) Injection after Microlaryngoscopic Surgery for PRP Group and Conventional Microlaryngoscopic Surgery (Active Comparator) in people with Benign Vocal Fold Lesions, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate whether platelet-rich plasma (PRP) injections can improve voice outcomes after microlaryngosurgery in patients with benign vocal fold lesions. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Benign Vocal Fold Lesions
- What is being tested?
- Platelet-Rich Plasma (PRP) Injection after Microlaryngoscopic Surgery for PRP Group and Conventional Microlaryngoscopic Surgery (Active Comparator)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Mar 2025to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 to 50 years
- Diagnosis of a benign vocal fold lesion, including: Vocal fold polyps Vocal fold cysts Vocal fold nodules
- Failure to respond to conservative management, including one or more of the following: Voice rest, voice therapy
Who cannot join
- Age younger than 18 years or above 50
- Medically unfit for surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Beni Suef Univesity hospital
Banī Suwayf, Egypt, 3220001
Shaimaa Bakia, 01145335408, shaimaa.saleh@med.bsu.edu.eg
About this study
Official title: Evaluating The Efficacy of Platelet Rich Plasma on Voice Outcomes Following Surgical Removal of Benign Vocal Fold Lesions
The goal of this clinical trial is to evaluate whether platelet-rich plasma (PRP) injections can improve voice outcomes after microlaryngosurgery in patients with benign vocal fold lesions. The main questions it aims to answer are:
Does postoperative PRP injection improve vocal quality compared to conventional surgery alone?
Read more
Does PRP injection reduce vocal fatigue and improve patients' voice-related quality of life?
Researchers will compare 32 patients receiving PRP injections after surgical removal of lesions (intraoperative injection) to 32 patients undergoing conventional surgery without PRP to see if PRP enhances recovery and voice function.
Participants will:
Undergo microlaryngosurgery to remove benign vocal fold lesions.
Receive a PRP injection to the operated vocal fold and standard postoperative care.
Or Standard postoperative care only.
Complete voice assessments before surgery and at 1 and 3 months after surgery, including:
Auditory perceptual evaluation (GRBAS scale) Videostroboscopy Acoustic and aerodynamic voice analysis Vocal Fatigue Index (VFI)
All participants will provide written consent and undergo standard preoperative assessments including medical history, ENT examination, laboratory tests, ECG, and anesthesia evaluation.
Read the detailed description
Benign vocal fold lesions are commonly treated with microlaryngosurgery when conservative management fails; however, postoperative voice recovery may be variable, and some patients experience persistent dysphonia or vocal fatigue. Platelet-rich plasma (PRP) has been proposed as a biologic adjunct that may enhance tissue healing through its regenerative and anti-inflammatory properties.
This clinical trial evaluates the effect of postoperative PRP injection as an adjunct to microlaryngosurgery for benign vocal fold lesions. The study compares voice recovery in patients receiving PRP injection during surgery with those receiving conventional postoperative management alone.
Adult patients undergoing microlaryngosurgery for benign vocal fold lesions will be enrolled and allocated to one of two study groups: a PRP injection group or a conventional treatment group. All participants will undergo standard surgical management, with the intervention group receiving an additional PRP injection to the operated vocal fold.
Voice outcomes will be assessed longitudinally at predefined postoperative intervals using objective, perceptual, and patient-reported measures. These assessments are intended to evaluate postoperative voice quality, vocal function, and patient-perceived vocal fatigue.
All participants will undergo routine preoperative evaluation and provide written informed consent in accordance with institutional and ethical guidelines.
This study aims to determine whether PRP injection provides additional benefit in voice recovery following microlaryngosurgery for benign vocal fold lesions.
- Conditions
- Benign Vocal Fold Lesions
- Being tested
- Platelet-Rich Plasma (PRP) Injection after Microlaryngoscopic Surgery for PRP Group, Conventional Microlaryngoscopic Surgery (Active Comparator)
- Keywords
- vocal fold polyp, vocal fold nodules, vocal fold cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich Plasma (PRP) Injection after Microlaryngoscopic Surgery for PRP GroupProcedure or surgery
Platelet-Rich Plasma (PRP) Injection Patients in this group will undergo microlaryngoscopic removal of benign vocal fold lesions under general anesthesia. Following surgery, autologous PRP will be injected into the superficial lamina propria (Reinke's space), just lateral to the excision site, using a Chiba needle. The injection aims to promote tissue regeneration, improve postoperative healing, and enhance vocal quality. Care is taken to avoid the free edge of the vocal fold to minimize scarring or stiffness. The PRP is prepared fresh from the patient's blood on the day of injection.
Conventional Microlaryngoscopic Surgery (Active Comparator)Procedure or surgery
Patients in this group will undergo microlaryngoscopic removal of benign vocal fold lesions under general anesthesia without PRP injection. Standard postoperative care is provided. This group serves as a comparator to evaluate the additional effect of PRP on voice recovery.
| Study group | Role | What they receive |
|---|---|---|
| PRP Group | Experimental | Patients in this group will undergo microlaryngoscopic removal of benign vocal fold lesions followed by an injection of platelet-rich plasma (PRP) into the superficial lamina propria (Reinke's space) just lateral to the excision site. This intervention aims to promote tissue regeneration, improve vocal fold healing, and enhance postoperative voice outcomes. Receives: Procedure: Platelet-Rich Plasma (PRP) Injection after Microlaryngoscopic Surgery for PRP Group |
| Conventional Surgery Group | Active comparator | Control (Conventional Surgery) Group
Role: Control group for comparison.
Description: Patients in this group will undergo microlaryngoscopic removal of benign vocal fold lesions without PRP injection. Standard postoperative care will be provided. This arm serves as the baseline to assess the additional effect of PRP on voice recovery and healing. Receives: Procedure: Conventional Microlaryngoscopic Surgery (Active Comparator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shimmer (Local, dB)
Shimmer (local), expressed in decibels (dB), representing cycle-to-cycle amplitude variation, will be obtained from sustained vowel /a/ using PRAAT software.
Measured: From enrollment, including baseline voice assessment, through surgery and postoperative follow-up assessments at 1 month and 3 months
Secondary outcomes (1)
Harmonic to noise Ratio
Harmonic to Noise Ratio, will be obtained from sustained vowel /a/ using PRAAT software.
Unit of Measure:
dB
Measured: Baseline (preoperative), 1 month postoperative, and 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start4 Mar 2025
- Primary completion29 May 2026
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Vocal Fold LesionsStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The surgery will be performed under general anesthesia. All patients will undergo microlaryngoscopic removal of the vocal fold lesions under microscopic or endoscopic guidance using a rigid laryngoscope, and hemostasis will be achieved. For patients in the PRP group, 0.25-1.5 mL of PRP will be injected into the superficial lamina propria (Reinke's space), just lateral to the excision site, using a Chiba needle. This site is chosen to promote tissue regeneration without damaging the vocal ligament or muscle, while slightly medializing the vocal fold for better glottic closure. Care will be taken to avoid the free edge of the vocal fold, as direct injection there can cause scarring, stiffness, or worsening of voice quality. The injection volume will typically range from 0.25 to 1.5 mL depending on the size of the lesion and the vocal fold.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa A Bakia, Beni-Suef University
- Investigators
- Shaimaa Ahmed Bakia, Principal investigator, Lecturer of Phoniatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300800
- Sponsor's protocol ID
- FMBSUREC/04032025/Mohammed
- Status last verified
- May 2026
- First submitted
- 4 Dec 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating The Efficacy of Platelet Rich Plasma on Voice Outcomes Following Surgical Removal of Benign Vocal Fold Lesions
- ClinicalTrials.gov ID
- NCT07300800
- Acronym / sponsor ID
- FMBSUREC/04032025/Mohammed
- Conditions
- Benign Vocal Fold Lesions
- Keywords
- vocal fold polyp, vocal fold nodules, vocal fold cyst
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 29 May 2026 (actual)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 24 Dec 2025 (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.
The goal of this clinical trial is to evaluate whether platelet-rich plasma (PRP) injections can improve voice outcomes after microlaryngosurgery in patients with benign vocal fold lesions. The main questions it aims to answer are:
Does postoperative PRP injection improve vocal quality compared to conventional surgery alone?
Does PRP injection reduce vocal fatigue and improve patients' voice-related quality of life?
Researchers will compare 32 patients receiving PRP injections after surgical removal of lesions (intraoperative injection) to 32 patients undergoing conventional surgery without PRP to see if PRP enhances recovery and voice function.
Participants will:
Undergo microlaryngosurgery to remove benign vocal fold lesions.
Receive a PRP injection to the operated vocal fold and standard postoperative care.
Or Standard postoperative care only.
Complete voice assessments before surgery and at 1 and 3 months after surgery, including:
Auditory perceptual evaluation (GRBAS scale) Videostroboscopy Acoustic and aerodynamic voice analysis Vocal Fatigue Index (VFI)
All participants will provide written consent and undergo standard preoperative assessments including medical history, ENT examination, laboratory tests, ECG, and anesthesia evaluation.
Detailed description
Benign vocal fold lesions are commonly treated with microlaryngosurgery when conservative management fails; however, postoperative voice recovery may be variable, and some patients experience persistent dysphonia or vocal fatigue. Platelet-rich plasma (PRP) has been proposed as a biologic adjunct that may enhance tissue healing through its regenerative and anti-inflammatory properties.
This clinical trial evaluates the effect of postoperative PRP injection as an adjunct to microlaryngosurgery for benign vocal fold lesions. The study compares voice recovery in patients receiving PRP injection during surgery with those receiving conventional postoperative management alone.
Adult patients undergoing microlaryngosurgery for benign vocal fold lesions will be enrolled and allocated to one of two study groups: a PRP injection group or a conventional treatment group. All participants will undergo standard surgical management, with the intervention group receiving an additional PRP injection to the operated vocal fold.
Voice outcomes will be assessed longitudinally at predefined postoperative intervals using objective, perceptual, and patient-reported measures. These assessments are intended to evaluate postoperative voice quality, vocal function, and patient-perceived vocal fatigue.
All participants will undergo routine preoperative evaluation and provide written informed consent in accordance with institutional and ethical guidelines.
This study aims to determine whether PRP injection provides additional benefit in voice recovery following microlaryngosurgery for benign vocal fold lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The surgery will be performed under general anesthesia. All patients will undergo microlaryngoscopic removal of the vocal fold lesions under microscopic or endoscopic guidance using a rigid laryngoscope, and hemostasis will be achieved. For patients in the PRP group, 0.25-1.5 mL of PRP will be injected into the superficial lamina propria (Reinke's space), just lateral to the excision site, using a Chiba needle. This site is chosen to promote tissue regeneration without damaging the vocal ligament or muscle, while slightly medializing the vocal fold for better glottic closure. Care will be taken to avoid the free edge of the vocal fold, as direct injection there can cause scarring, stiffness, or worsening of voice quality. The injection volume will typically range from 0.25 to 1.5 mL depending on the size of the lesion and the vocal fold.
| Arm | Type | Receives |
|---|---|---|
| PRP Group | Experimental | Procedure: Platelet-Rich Plasma (PRP) Injection after Microlaryngoscopic Surgery for PRP GroupPatients in this group will undergo microlaryngoscopic removal of benign vocal fold lesions followed by an injection of platelet-rich plasma (PRP) into the superficial lamina propria (Reinke's space) just lateral to the excision site. This intervention aims to promote tissue regeneration, improve vocal fold healing, and enhance postoperative voice outcomes. |
| Conventional Surgery Group | Active comparator | Procedure: Conventional Microlaryngoscopic Surgery (Active Comparator)Control (Conventional Surgery) Group Role: Control group for comparison. Description: Patients in this group will undergo microlaryngoscopic removal of benign vocal fold lesions without PRP injection. Standard postoperative care will be provided. This arm serves as the baseline to assess the additional effect of PRP on voice recovery and healing. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
Key exclusion criteria (2 listed)
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 Plasma (PRP) Injection after Microlaryngoscopic Surgery for PRP GroupPlatelet-Rich Plasma (PRP) Injection Patients in this group will undergo microlaryngoscopic removal of benign vocal fold lesions under general anesthesia. Following surgery, autologous PRP will be injected into the superficial lamina propria (Reinke's space), just lateral to the excision site, using a Chiba needle. The injection aims to promote tissue regeneration, improve postoperative healing, and enhance vocal quality. Care is taken to avoid the free edge of the vocal fold to minimize scarring or stiffness. The PRP is prepared fresh from the patient's blood on the day of injection. | Procedure or surgery | PRP Group |
| Conventional Microlaryngoscopic Surgery (Active Comparator)Patients in this group will undergo microlaryngoscopic removal of benign vocal fold lesions under general anesthesia without PRP injection. Standard postoperative care is provided. This group serves as a comparator to evaluate the additional effect of PRP on voice recovery. | Procedure or surgery | Conventional Surgery Group |
Primary outcome
Shimmer (Local, dB)
Time frame: From enrollment, including baseline voice assessment, through surgery and postoperative follow-up assessments at 1 month and 3 months
Shimmer (local), expressed in decibels (dB), representing cycle-to-cycle amplitude variation, will be obtained from sustained vowel /a/ using PRAAT software.
1 secondary outcome
Harmonic to noise Ratio
Time frame: Baseline (preoperative), 1 month postoperative, and 3 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Benign Vocal Fold Lesions
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Voice and Voice Disorders
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.
Shaimaa Ahmed Bakia principal investigator
Lecturer of Phoniatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-Rich Plasma (PRP) Injection after Microlaryngoscopic Surgery for PRP Group and Conventional Microlaryngoscopic Surgery (Active Comparator) in people with Benign Vocal Fold Lesions, run by Beni-Suef University at 1 site in Egypt.
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 3 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: looking for participants now, as of the sponsor's last update on 1 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shaimaa Bakia, Lecturer (+201145335408, shaimaa.saleh@med.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shimmer (Local, dB) (time frame: From enrollment, including baseline voice assessment, through surgery and postoperative follow-up assessments at 1 month and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2026.