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

NCT07300800 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-05-19

No results posted yet for this study

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. 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.

Conditions

  • Benign Vocal Fold Lesions

Interventions

PROCEDURE

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, 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

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.

Sponsors & Collaborators

  • Beni-Suef University

    lead OTHER

Principal Investigators

  • Shaimaa Ahmed Bakia · Lecturer of Phoniatrics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-04
Primary Completion
2026-06-25
Completion
2026-07-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07300800 on ClinicalTrials.gov