Role of Nanoemulsified Sesame Oil in Post-operative Care After Endoscopic Sinus Surgery

Mansoura University

Status: Completed

Conditions: Chronic Rhinosinusitis (Diagnosis)

Treatments: Other: application of different topical nasal solutions

Study type: Interventional

Funder types: Other

Identifiers

NCT06437717

MS.20.5.1134

Details and patient eligibility

About

The goal of our thesis is to design, develop and characterize a novel thermodynamically stable NE by spontaneous method intended for topical use. Subsequently, appraisal of nanoemulsified sesame oil formulation has been performed on the post-operative symptoms in CRS patients who have undergone ESS (endoscopic sinus surgery) combined with different types of nasal irrigation which may affect formulation efficacy.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient age between 18 and 60 years old.
2. chronic rhinosinusitis patients who have undergone endoscopic sinus surgery.

Exclusion criteria

1. Patients with history of allergy for sesame seed derivatives.
2. Patients with chronic diseases which affecting the process of healing (uncontrolled DM, renal failure and hepatic failure).
3. Patients with nasal granulomas.
4. Patients with invasive fungal rhinosinusitis.
5. Smokers.
6. Patients with history of radio and/or chemotherapy exposure.
7. Patients with systemic diseases affecting integrity of nasal mucosa (e.g. CF, scleroderma, Sjogren syndrome ...).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 4 patient groups

only normal saline as nasal irrigation

Active Comparator group

Treatment:

Other: application of different topical nasal solutions

normal saline as nasal irrigation followed by sesame oil nasal drops

Active Comparator group

Treatment:

Other: application of different topical nasal solutions

only Ringer's lactate solution as nasal irrigation

Active Comparator group

Treatment:

Other: application of different topical nasal solutions

Ringer's lactate solution as nasal irrigation followed by sesame oil nasal drops

Active Comparator group

Treatment:

Other: application of different topical nasal solutions