Chronic rhinosinusitis with or without nasal polyps, planning to undergo unilateral/bilateral endoscopic sinus surgery
Conditions
Interventions
Nasal surgery trial group:Use of the investigational degradable otorhinolaryngological hemostatic sponge for postoperative nasal packing and hemostasis after nasal surgery
Nasal surgery control group:Use of the control product for postoperative nasal packing and hemostasis after nasal surgery
Ear surgery trial group:Use of the investigational degradable otorhinolaryngological hemostatic sponge for postoperative packing and hemostasis after ear surgery
Ear surgery control group:Use of the control product for postoperative packing and hemostasis after ear surgery
Sponsors
Eye and ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old, regardless of gender; 2. Any of the following: (1) Chronic rhinosinusitis with or without nasal polyps, planning to undergo unilateral/bilateral endoscopic sinus surgery; (2) Traumatic tympanic membrane perforation or resting chronic purulent otitis media, planned to undergo unilateral type I tympanoplasty; 3. Able to understand the purpose of the trial and willing to comply with all treatment and follow-up, voluntarily participate and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Preoperative coagulation dysfunction, platelets, prothrombin time and activated partial thromboplastin time are not within the normal range and judged by the investigator to be clinically significant; 2. Use of drugs affecting coagulation function within 1 week prior to surgery; 3. Those who are in the acute stage of systemic or local infection at the surgical site and are not suitable for surgery as judged by the investigator; 4. Those who are using immunosuppressants for more than 3 months; 5. Adverse effects on test/control product materials (potato starch, alginate and glycerin; polyether ester and polyurethane polymers, etc.) or those with severe allergies; 6. With severe neurological or psychiatric diseases who cannot cooperate with the completion of the trial; 7. Pregnant or lactating women, or those who have a birth plan during the trial; 8. Who have participated in or are participating in drug clinical trials within 90 days prior to screening, or who have participated or are participating in other medical device clinical trials within 30 days; 9. Who are considered by the investigator to be inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemostasis efficacy rate at 24 hours postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device performance evaluation;Hemostasis efficacy rate at 10 minutes postoperatively;Numerical Rating Scale (NRS) pain score;Sinonasal Outcome Test-22 (SNOT-22) score;Lund-Kennedy endoscopic scoring system;Tympanic membrane healing status;Hearing status of operated ear;Eustachian tube function score (ETS);Device degradation status; | — |
Countries
China
Contacts
Public ContactYu Hongmeng
Eye and ENT Hospital of Fudan University
Outcome results
None listed