Clinical study on fibroblast growth factor administration to nasal septal perforation

JRCT ID: jRCTs031220604

Registered date:01/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: nasal septal perforation
• Date of first enrollment: 25/03/2023
• Target sample size: 10
• Study type: Interventional

Intervention(s)

For nasal septal perforation (target), a gelatin sponge is infiltrated with the entire trafermin (genetically modified) solution and molded, and after fresh wounding of the nasal septal perforation margin, the sponge is placed to seal the nasal septal perforation area without gaps.
If necessary, a collagen sponge is added and fixed using a silicone plate.

Outcome(s)

• Primary Outcome: Rate of occurrence of adverse events and their details/severity

Secondary Outcome

1) Nasal septal perforation closure at 16th week of observation period
2) Findings of nasal septal perforation (comparison between the previous observation period and the 4th, 8th, and 16th week of the observation period)
3) Presence or absence of infection, crust, or granulation at the margin of nasal septal perforation (comparison between the previous observation period and the 4th, 8th, and 16th week of the observation period)
4) Degree of improvement of subjective symptoms using the nasal symptom questionnaire and the Sino-Nasal Outcome Test (SNOT-22) (comparison between the previous observation period and weeks 4, 8, and 16 of the observation period)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Persons with perforation of the nasal septum visible by nasal fiberscope.
2)Those with nasal septal perforation for at least six months
3)Age at the time of obtaining consent is at least 20 years
4)Persons who have given their free and written consent

Exclude criteria

1) Patients with serious hepatic, renal, or circulatory disorders
2) Patients with malignant tumors
3) Patients with a history of serious drug allergy or serious adverse drug reactions such as anaphylactic shock, those with a history of allergy to gelatin, and those allergic to anesthetics
4) Patients who have participated in a clinical trial and taken an investigational drug within 4 weeks prior to obtaining consent
5) Patients who are scheduled to undergo surgical treatment between the time consent is obtained and the end of the study period
6) Patients who are pregnant or may become pregnant
7) Patients who are breast-feeding
8) Patients who have uncontrolled diabetes mellitus
9) Patients with poorly controlled sinusitis or allergic rhinitis
10) Patients at high risk of bleeding who are taking anticoagulants or antiplatelet agents
11) Patients who are easily infected by autoimmune diseases, acquired immunodeficiency syndrome, taking immunosuppressive drugs
12) Other subjects who are deemed inappropriate to participate in this research by the principal investigator (subinvestigator)

Related Information

• Primary Sponsor: Otori Nobuyoshi