Design and Application of Nasal Stents

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

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

Study Overview

• Status: Completed
• Conditions: Nasal Septum; Deviation, Congenital
• Intervention / Treatment: Device: nasal stents; Device: merocel

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nasal stents; using nasal stents after septoplasty	Device: nasal stents; using nasal stents after septoplasty
Other: merocel; using merocel as nasal packing after septoplasty	Device: merocel; using merocel after septoplasty

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Junxiu Liu, Peking University Third Hosptial

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2020
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: December 28, 2021
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 28, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hemostatics; Coagulants; Polyvinyl alcohol formaldehyde foam
• Other Study ID Numbers: PUTH-NS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No