Design and Application of Nasal Stents

NCT05243147 | Completed

• 1 other identifier: PUTH-NS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nasal Septum; Deviation, Congenital

Outcome Measures

Primary Outcomes (1)

• Effective rate of packing

  (1) In the period of nasal tamponade and after the removal of the tamponade instrument (48 h ± 1 h after surgery), the nasal bleeding score was ≤ 2 points; (2) 48 h ± 1 h after the completion of nasal tamponade, the overall discomfort score ≤ 7 points; (3) No septal hematoma and nasal adhesions were confirmed by nasal endoscopy at 30 days ± 5 days after the operation. Nasal tamponade is considered effective when the above 3 criteria are met.

  2days after operation

Secondary Outcomes (2)

• visual analog scale（VAS）of comfort

  2days after operation

• security

  30days after operation

Study Arms (2)

nasal stents

EXPERIMENTAL

using nasal stents after septoplasty

Device: nasal stents

merocel

OTHER

using merocel as nasal packing after septoplasty

Device: merocel

Interventions

nasal stents DEVICE

using nasal stents after septoplasty

nasal stents

merocel DEVICE

using merocel after septoplasty

merocel

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects voluntarily participate in the experiment and sign the informed consent;
• Age range from 18 to 70 years old, gender unlimited;
• 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);
• No history of respiratory tract infection and nasal decongestant use within 1 month before the visit;
• No other treatment was used;
• ASA grade 1\~2;
• Able to communicate well with researchers and follow the requirements of the experiment.

You may not qualify if:

• There are acute and chronic rhinosinusitis, nasal polyps, benign and malignant tumors and other nasal diseases;
• History of craniocerebral and nasal surgery;
• The results of preoperative coagulation function test exceeded 20% of the upper limit of normal value;
• Patients known to be allergic to test instrument materials;
• Pregnant or lactating women;
• 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;
• Participants who have participated in other clinical trials within the last 1 month;
• Participants considered unsuitable for this clinical trial for other reasons.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Study Officials

• Junxiu Liu

  Peking University Third Hosptial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: February 16, 2022
• Study Start: October 22, 2020
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: May 31, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)