Design and Application of Nasal Stents

Not Applicable

Completed

• Conditions: Nasal Septum; Deviation, Congenital
• Interventions: Device: nasal stents; Device: merocel

• Registration Number: NCT05243147
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study Start: 2020-10-22
• Study First Submitted: 2021-12-28
• Study First Submitted QC: 2022-02-07
• Study First Posted: 2022-02-16
• Primary Completion: 2022-08-30
• Study Completion: 2022-08-30
• Status Verified: 2022-12
• Last Update Submitted: 2023-05-28
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nasal stents	nasal stents	using nasal stents after septoplasty
merocel	merocel	using merocel as nasal packing after septoplasty

Primary Outcome Measures

Name	Time	Method
Effective rate of packing	2days after operation	(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.

Secondary Outcome Measures

Name	Time	Method
visual analog scale（VAS）of comfort	2days after operation	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)
security	30days after operation	The incidence of complications and adverse events were used as safety evaluation indexes

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China