Design and Application of Nasal Stents

Nasal Septum; Deviation, Congenital Clinical Trial

Official title:

Clinical Control Study of Application of Nasal Stent and Merocel Sponge After Nasal Septoplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05243147
• Other study ID #: PUTH-NS
• Status: Completed
• Phase: N/A
• Start date: October 22, 2020
• Est. completion date: August 30, 2022

Study information

• Verified date: December 2022
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nasal Septum; Deviation, Congenital

Intervention

Device:
• nasal stents
using nasal stents after septoplasty
• merocel
using merocel after septoplasty

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	visual analog scale(VAS)of comfort	including nasal congestion, nasal pain, headache, itchy nose sneezing, watery tears, runny nose, nasal reflux, facial swelling, difficulty swallowing, sleep disturbance, dry mouth, and general discomfort. The severity of each symptom was graded using the visual analog scale (VAS) of 0 (none) to10 (unbearable)	2days after operation
Secondary	security	The incidence of complications and adverse events were used as safety evaluation indexes	30days after operation