RecruitingNot ApplicableNCT07300800

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

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


Sponsor

Beni-Suef University

Enrollment

64 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria3

  • * 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 Criteria2

  • Age younger than 18 years or above 50
  • Medically unfit for surgery

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Interventions

PROCEDUREPlatelet-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.

PROCEDUREConventional 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.


Locations(1)

Beni Suef Univesity hospital

Banī Suwayf, Egypt, Egypt

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NCT07300800