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Effect of PRP Injection on Voice Recovery After Benign Vocal Fold Surgery

NCT ID: NCT07300800

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-10

Study Completion Date

2026-07-30

Brief Summary

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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 surgery 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 either a PRP injection to the operated vocal fold or standard postoperative care.

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

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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 following 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

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Benign Vocal Fold Lesions

Keywords

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Vocal fold polyps Vocal fold cysts Vocal fold nodules Vocal fold atrophy Vocal fold sulcus Vocal fold scar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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, 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 0.5 to 1.5 mL depending on the size of the lesion and the vocal fold.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcome Assessors / Voice Analysts: masked to group assignment to avoid assessment bias when evaluating voice outcomes (GRBAS, VFI, acoustic analysis).

Study Groups

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PRP Group

Patients in this group will undergo microlaryngoscopic removal of benign vocal fold lesions followed by an injection of 1.5 mL 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.

Group Type EXPERIMENTAL

Platelet-Rich Plasma (PRP) Injection after Microlaryngoscopic Surgery for PRP Group

Intervention Type PROCEDURE

Platelet-Rich Plasma (PRP) Injection Patients in this group will undergo microlaryngoscopic removal of benign vocal fold lesions under general anesthesia. Following surgery, 1.5 mL of 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 Surgery Group

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.

Group Type ACTIVE_COMPARATOR

Conventional Microlaryngoscopic Surgery (Active Comparator)

Intervention Type PROCEDURE

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.

Interventions

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Platelet-Rich Plasma (PRP) Injection after Microlaryngoscopic Surgery for PRP Group

Platelet-Rich Plasma (PRP) Injection Patients in this group will undergo microlaryngoscopic removal of benign vocal fold lesions under general anesthesia. Following surgery, 1.5 mL of 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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\* Adults aged 18 to 50 years

\* Diagnosis of a benign vocal fold lesion, including: Vocal fold polyps Vocal fold cysts Vocal fold nodules Vocal fold atrophy Vocal fold sulcus Vocal fold scar

\* Failure to respond to conservative management, including one or more of the following: Voice rest, voice therapy

Exclusion Criteria

* Age younger than 18 years or above 50
* Medically unfit for surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Shaimaa A Bakia

Lecturer of Phoniatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shaimaa Ahmed Bakia

Role: PRINCIPAL_INVESTIGATOR

Lecturer of Phoniatrics

Central Contacts

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Shaimaa Bakia, Lecturer

Role: CONTACT

Phone: +201145335408

Email: [email protected]

Other Identifiers

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FMBSUREC/04032025/Mohammed

Identifier Type: -

Identifier Source: org_study_id