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NCT Number: NCT05688488

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

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.

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Key information

Conditions

Glottic Web of Larynx Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Glottic Carcinoma Laryngeal Diseases Laryngeal Leucoplakia Laryngeal Papilloma Laryngeal Polyp Laryngeal Stenosis Laryngeal papillomatosis Laryngostenosis Otorhinolaryngologic Diseases Respiratory System Abnormalities Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location status: Recruiting

Location contact

Jian Chen

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

curcumin

Drug

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.

mitomycin-C

Drug

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.

Primary outcomes

  1. Number of participants with laryngeal web formation as assessed by videolaryngoscope

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Haitao Wu, Ph.D

CONTACT

[email protected]

+8621-64377134

Jian Chen, Ph.D

CONTACT

[email protected]

+8621-64377134

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 18, 2023
Registry last updated
May 6, 2023

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.

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