Clinical trial NCT05243147: Design and Application of Nasal Stents
Official title: Clinical Control Study of Application of Nasal Stent and Merocel Sponge After Nasal Septoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Septum; Deviation, Congenital
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Effective rate of packing
timeFrame: 2days after operation
Secondary outcomes:
measure: visual analog scale（VAS）of comfort
timeFrame: 2days after operation
measure: security
timeFrame: 30days after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hosptial
name: Junxiu Liu
role: PRINCIPAL_INVESTIGATOR
References: