Beni Suef Univesity hospital
Banī Suwayf, Egypt, 3220001
Location status: Recruiting
Recruiting
NCT Number: NCT07300800
Effect of PRP Injection on Voice Recovery After Benign Vocal Fold Surgery
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–50 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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 during 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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
- 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
Treatment and study plan
Platelet-Rich Plasma (PRP) Injection after Microlaryngoscopic Surgery for PRP Group
ProcedurePlatelet-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)
ProcedurePatients 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.
Primary outcomes
-
Shimmer (Local, dB)
Time frame: 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.
Secondary outcomes
-
Harmonic to noise Ratio
Time frame: Baseline (preoperative), 1 month postoperative, and 3 months postoperative
Harmonic to Noise Ratio, will be obtained from sustained vowel /a/ using PRAAT software.
Unit of Measure:
dB
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Beni-Suef University
Other
Registry information
Official study title
Evaluating The Efficacy of Platelet Rich Plasma on Voice Outcomes Following Surgical Removal of Benign Vocal Fold Lesions
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Dec 24, 2025
- Registry last updated
- Jun 1, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.