Clinical Study of Curcumin in Preventing Postoperative Adhesion of Bilateral Vocal Cords

Sponsor

Eye & ENT Hospital of Fudan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05688488

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To provide a novel therapy idea and method to solve the clinical problem of postoperative adhesion of bilateral vocal cords, patients enrolled in this study will be applied with curcumin on both wound sites of bilateral vocal cords after the surgery on the bilateral vocal cord endoscopically.

Condition or Disease	Intervention/Treatment	Phase
Glottic Web of Larynx Laryngeal Stenosis Glottic Carcinoma Laryngeal Leucoplakia Laryngeal Polyp Laryngeal Papilloma	Drug: Curcumin Drug: Mitomycin-C	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Clinical Study of Curcumin in Preventing Postoperative Adhesion of Bilateral Vocal Cords

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Curcumin	Drug: Curcumin Curcumin was applied to both wound sites of bilateral vocal cords. After evenly applied, gently massage the applied site for 3-5 minutes until the drug was fully absorbed.
Active Comparator: Mitomycin	Drug: Mitomycin-C Mitomycin-C was applied to both wound sites of bilateral vocal cords. After evenly applied, gently massage the applied site for 3-5 minutes until the drug was fully absorbed.

Arm

Intervention/Treatment

Experimental: Curcumin

Drug: Curcumin

Curcumin was applied to both wound sites of bilateral vocal cords. After evenly applied, gently massage the applied site for 3-5 minutes until the drug was fully absorbed.

Active Comparator: Mitomycin

Drug: Mitomycin-C

Mitomycin-C was applied to both wound sites of bilateral vocal cords. After evenly applied, gently massage the applied site for 3-5 minutes until the drug was fully absorbed.

Outcome Measures

Primary Outcome Measures

Number of participants with laryngeal web formation as assessed by videolaryngoscope [1 year postsurgery]
All participants received the videolaryngoscope every month post-surgery, and a laryngeal web is defined as a visible adhesion whose length reached 1 mm or greater.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with bilateral vocal cord diseases who are going to undergo resection of bilateral vocal cord lesions endoscopically.
Patients with bilateral vocal cord adhesion who are going to undergo incision of bilateral vocal cord adhesion endoscopically.

Exclusion Criteria:

Patients with other laryngeal diseases.
Patients with cardiac and pulmonary insufficiency.
Patients unable to cooperate with the follow-up on time after surgery.
Patients who refuse to sign the informed consent after notification.
Patients who have a severe allergic disease or allergic history to a variety of drugs.
Other circumstances that are not appropriate to be included in the clinical trial.