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NOT YET RECRUITING
NCT07300800
NA

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

Sponsor: Beni-Suef University

View on ClinicalTrials.gov

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 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.

Official title: Evaluating The Efficacy of Platelet Rich Plasma on Voice Outcomes Following Surgical Removal of Benign Vocal Fold Lesions

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2025-12-10

Completion Date

2026-07-30

Last Updated

2025-12-24

Healthy Volunteers

No

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, 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.

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.