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Clinical Trials in Egypt / NCT07300800
Recruiting Not applicable

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

NCT07300800 · tracked via the Priya Life Science Egypt tracker
Sponsor
Beni-Suef University
Phase
Not applicable
Started
2025-03-04
Last updated
2026-06-01

Condition(s) studied

Benign Vocal Fold Lesions

Investigational drug(s) / intervention(s)

Platelet-Rich Plasma (PRP) Injection after Microlaryngoscopic Surgery for PRP GroupConventional Microlaryngoscopic Surgery (Active Comparator)

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.

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
* 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 \* 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

Primary outcome measure(s)

  • Shimmer (Local, dB) — From enrollment, including baseline voice assessment, through surgery and postoperative follow-up assessments at 1 month and 3 months
    Shimmer (local), expressed in decibels (dB), representing cycle-to-cycle amplitude variation, will be obtained from sustained vowel /a/ using PRAAT software.

Trial sites (1)

FacilityCityRegionStatus
Beni Suef Univesity hospital Banī Suwayf Egypt Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07300800 on ClinicalTrials.gov ↗ ← All trials in Egypt