Skip to main content
OpenTrials
Completed

NCT Number: NCT05243147

Design and Application of Nasal Stents

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nasal Septum; Deviation, Congenital

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nasal stents

Device

using nasal stents after septoplasty

merocel

Device

using merocel after septoplasty

Primary outcomes

  1. Effective rate of packing

    Time frame: 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 outcomes

  1. visual analog scale（VAS）of comfort

    Time frame: 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)

  2. security

    Time frame: 30days after operation

    The incidence of complications and adverse events were used as safety evaluation indexes

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 16, 2022
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.