Health Condition 1: J32- Chronic sinusitis
Conditions
Interventions
Intervention1: MEROCEL manufactured by Medtronic.: Merocel is a compressed, dehydrated sponge composed of hydroxylated polyvinyl acetate. They are highly absorbent, providing effective hemostasis by e
Sponsors
Dr Akhil Pratap Singh Trial Investigator
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject eligible for the use of a nasal pack (either VELNEZ, Merocel or Rapid Rhino) in routine clinical practice after a planned nasal surgery. 2. Male and female in the age group of 18 to 70 years. (Both Included) 3. Subjects who can provide informed consent form in writing. 4. Subjects who allow their study data to be collected at pre-defined follow-up period.
Exclusion criteria
Exclusion criteria: 1. Subject who are unable to be treated with the other than VELNEZ, Merocel or Rapid Rhino nasal pack in routine clinical practice after a planned nasal surgery. 2. Subject unwilling or unable to comply with the postoperative visits necessary for data collection. 3. Subject with an active infection at the surgery site. 4. Subject with a history of asthma. 5. Subject who are on aspirin or anti-platelet drugs therapy. 6. Hypertensive subjects. 7. Subjects who have a history of allergy (Hypersensitive) reactions with any of the ingredients of the nasal pack. 8. Subject with bleeding disorders. 9. Any medical condition that, in the opinion of the investigator, would make the subject unsuitable for inclusion (e.g., a chronic, relapsing or hereditary disease that may interfere with the outcome of the study)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess and compare the efficacy of the nasal packs (VELNEZ, Merocel, or Rapid Rhino) in ceasing reactive bleeding and achieving secondary bleeding control in post-operative nasal surgery patients. This will be evaluated based on the duration and extent of bleeding cessation observed with each nasal pack. The assessment of synechiae formation among the various nasal pack groups. The presence and extent of adhesions between the nasal mucosa and other structures will be evaluated to determine the incidence of synechiae formation. The assessment of safety based on adverse events reported with the application of the nasal packs used. Any adverse reactions, complications, or adverse events related to the use of nasal packs will be documented and compared between the different nasal pack groups.Timepoint: 3 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-reported discomfort associated with the use of nasal packs post-surgery is an important endpoint. This will include assessing discomfort caused by the presence of the nasal pack, discomfort during its removal (including pressure and pain), and overall discomfort experienced by patients during the post-operative period. Evaluation of bleeding through the nose following the removal of nasal packs will provide insights into the effectiveness of hemostasis and bleeding control achieved by each nasal pack type. Assessment of crust formation and adhesion to the nasal mucosa at 2 weeks post-surgery will provide information on the healing process and potential complications associated with each nasal pack type.Timepoint: 3 weeks | — |
Countries
India
Contacts
Public ContactDr Akhil Partap Singh
Department of ENT
Outcome results
None listed