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

Beni-Suef University

Status: Not yet enrolling

Conditions: Benign Vocal Fold Lesions

Treatments: Procedure: Platelet-Rich Plasma (PRP) Injection after Microlaryngoscopic Surgery for PRP Group; Procedure: Conventional Microlaryngoscopic Surgery (Active Comparator)

Study type: Interventional

Funder types: Other

Identifiers

NCT07300800

FMBSUREC/04032025/Mohammed

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

PRP Group

Experimental group

Description:

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.

Treatment:

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

Conventional Surgery Group

Active Comparator group

Description:

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.

Treatment:

Procedure: Conventional Microlaryngoscopic Surgery (Active Comparator)