Serial Platelet-Rich Plasma Injections for Vocal Fold Atrophy, Scar, and/or Sulcus Vocalis

University of Southern California

Status: Completed

Conditions: Sulcus Vocalis of Vocal Cord; Atrophy; Larynx; Presbylarynges; Presbylarynx; Dysphonia; Vocal Cord Atrophy; Vocal Fold Scar

Treatments: Procedure: Serial PRP injections

Study type: Interventional

Funder types: Other

Identifiers

NCT03749863

APP-18-05224

Details and patient eligibility

About

This study will investigate the safety and efficacy of four serial monthly vocal fold injections of platelet-rich plasma to treat dysphonia secondary to vocal fold atrophy, scar, and/or sulcus vocalis with glottal insufficiency

Full description

Vocal fold atrophy, scar, sulcus vocalis, glottal insufficiency with resulting dysphonia is a condition affecting millions of aging Americans, up to 35% of those 65 or older. Currently used treatment methods include voice therapy, injections of inert fillers, and laryngeal framework surgery. These modalities are imperfect with voice therapy requiring considerable time commitment, filler injections generally temporary in benefit, and surgery with increased risks. The investigators intend to conduct a single-arm study to assess the safety and efficacy of autologous platelet-rich plasma (PRP) injection for vocal fold atrophy, sulcus vocalis and scar. PRP is a substance purified from the patient's own blood that consists of platelets, growth factors, and other regenerative molecules that have been shown to promote rejuvenation in a variety of tissue types. Patients with vocal fold atrophy, sulcus vocalis, and scar identified in the USC Voice Center will be offered participation in a study to receive serial PRP injections in one vocal fold. Outcome measures evaluated pre- and post-injection and over follow-up visits will include various patient reported quality of life indices, objective clinical assessments of voice, and laryngeal videostroboscopy examinations. The investigators hypothesize that serial PRP injections will significantly improve vocal fold mucosal volume, morphology, and dysphonia in these patients with no adverse side effects.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Vocal fold atrophy, scar, and/or sulcus vocalis diagnosed on laryngeal video stroboscopy by a fellowship-trained laryngologist
• Patients with a pre-injection VHI-10 score of ≥ 10
• Willingness to follow study requirements and perform follow-up visits for up to 4 months following the procedure
• Ability to give informed consent

Exclusion criteria

• Other co-existing laryngeal pathology that would affect either the safety or potential benefit from PRP injection
• Current smoker
• Underlying coagulopathy, thrombocytopenia, or platelet dysfunction

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

14 participants in 1 patient group

Serial PRP injections

Experimental group

Description:

This arm will receive experimental intervention of serial monthly platelet-rich plasma (PRP) injections to a unilateral vocal fold mucosa for a total of 4 injections.

Treatment:

Procedure: Serial PRP injections