Design and Application of Nasal Stents

NCT ID: NCT05243147

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-22
• Study Completion Date: 2022-08-30

Brief Summary

Comparative study of nasal stents and nasal packing in patients undergoing septoplasty

Detailed Description

To investigate the safety and effectiveness of nasal stent in clinical application by comparing and observing the clinical effect and comfort of nasal stent and merocel sponge applied in nasal septoplasty. Methods: patients with nasal septal deviation were selected and randomly divided into nasal stent group (experimental group) and merocel sponge group (control group) according to the packing method. The hemostasis effect, comfort and complications of the two groups were compared during the packing period.

Conditions

Nasal Septum; Deviation, Congenital

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

nasal stents

using nasal stents after septoplasty

Group Type: EXPERIMENTAL

nasal stents

Intervention Type: DEVICE

using nasal stents after septoplasty

merocel

using merocel as nasal packing after septoplasty

Group Type: OTHER

merocel

Intervention Type: DEVICE

using merocel after septoplasty

Interventions

nasal stents

using nasal stents after septoplasty

Intervention Type: DEVICE

merocel

using merocel after septoplasty

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. The subjects voluntarily participate in the experiment and sign the informed consent;

2. Age range from 18 to 70 years old, gender unlimited;

3. With nasal congestion as the chief complaint, CT of sinus suggested deviation of nasal septum with indications of surgery (deviation of nasal septum affects breathing and nasal congestion is serious; High nasal septum deviation affects sinus drainage or causes reflex headache; Nasal septum spine often causes nasal bleeding; Nasal septum deviation affects eustachian tube function);

4. No history of respiratory tract infection and nasal decongestant use within 1 month before the visit;

5. No other treatment was used;

6. ASA grade 1~2;

7. Able to communicate well with researchers and follow the requirements of the experiment.

Exclusion Criteria

1. There are acute and chronic rhinosinusitis, nasal polyps, benign and malignant tumors and other nasal diseases;

2. History of craniocerebral and nasal surgery;

3. The results of preoperative coagulation function test exceeded 20% of the upper limit of normal value;

4. Patients known to be allergic to test instrument materials;

5. Pregnant or lactating women;

6. Other organoplastic or functional diseases complicated by the subjects limited their participation in the study and could not comply with the follow-up or affect the scientific integrity of the study;

7. Participants who have participated in other clinical trials within the last 1 month;

8. Participants considered unsuitable for this clinical trial for other reasons.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junxiu Liu

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hosptial

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

PUTH-NS

Identifier Type: -

Identifier Source: org_study_id