Health Condition 1: J99- Respiratory disorders in diseasesclassified elsewhere
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects across different age groups who require postsurgical splinting of the nasal septum and treated with MyNasal Internal Nasal Pre-cut Splints. 2.The Subject is willing and able to provide written Informed Consent by signing and dating the IRB or ECapproved Informed Consent Form. 3.When a Subject and LAR (Legally acceptable representative) are illiterate, a literate impartial witness is required during consenting. 4.If the Subject is not able to write on behalf of the Subject, the Subject`s LAR (Legally acceptable representative) can fill out the informed consent. 5.The Subject should be able to comply with protocol requirements and assessments. 6.Subjects requiring short-term post-surgical splinting of the nasal septum after procedure such as septoplasty, rhinoplasty, turbinate reduction, functional or cosmetic surgeries that necessitate internal nasal pre-cut splints 7.Subjects with conditions required nasal stabilization to prevent septal hematoma or adhesion formation post surgery. 8.Subjects with normal healing capacity and without contraindications to nasal surgeries.
Exclusion criteria
Exclusion criteria: 1. Without informed consent, the Subject is not eligible for the study. 2. Any sign of infection at the time of operation. 3. Previous history of any type of nasal surgery. 4. Any known hypersensitivity or allergic reaction to silicone or similar materials. 5. Subjects with severe nasal deformities or obstructions that make placement of the splint unfeasible. 6. Subjects with bleeding disorders that affect wound healing or increase surgical risks. 7. Women who are pregnant or breastfeeding. 8. Subjects with a known or suspected Cerebrospinal Fluid leak, as this condition may complicate the use of nasal pre-cut splints and increase the risk of postoperative complications such as infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Pain score 2.Nasal Airway patency Timepoint: 1.Time Frame: Pre and Post-operative, 7 days 2 days, 15 days 2 days, 1-month 7 days follow-up and 3-month 15 day follow-up 2.Time frame: Pre-operative and Post-operative | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total Operative time 2. Quality of life 3. Removal of Splint time 4. Mucosal healing after surgery 5. Structural Support and Stability 6. Complication and AE/SAE related to device 7. Ease of use Timepoint: 1. Time Frame: Intra-operative 2. Time Frame: Pre-operatively, Post-operatively, 7 days 2 days, 15 days 2 days, 1 month 7 days and 3 months 15 days follow-up 3. Time Frame : 7 days 2 days 4. Time frame: Postoperative, 7 days 2 days, 15 days 2 days, 1 month 7 days and 3 months 15 days 5. Time frame: Postoperative, 7 days 2 days, 15 days 2 days 6. Time Frame: Intra and post-operative, 7 days 2 days, 15 days 2 days, 1-month 7 daysfollow-up and 3-month 15 days follow-up 7. Time Frame: Intra-operative, 7 days 2 days | — |
Countries
India
Contacts
Public ContactDr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd
Outcome results
None listed