Design and Application of Nasal Stents

Study Overview
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Brief Summary
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Comparative study of nasal stents and nasal packing in patients undergoing septoplasty

Detailed Description
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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.

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

Conditions
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Nasal Septum; Deviation, Congenital

Intervention / Treatment
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* Device: nasal stents
* Device: merocel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nasal stents<br>using nasal stents after septoplasty | Device: nasal stents<br>* using nasal stents after septoplasty<br>|
| Other: merocel<br>using merocel as nasal packing after septoplasty | Device: merocel<br>* using merocel after septoplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| security | The incidence of complications and adverse events were used as safety evaluation indexes | 30days after operation |