Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637449
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Identification of Bacterial and Fungal Isolates in Patients with Sinonasal Polyps
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Identification of Bacterial and Fungal Isolates in Patients with Sinonasal Polyps
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To detect bacterial and fungal growth in patients with sinonasal polyps undergoing FESS
Detailed Description:
Chronic rhinosinusitis with nasal polyps CRSwNP is a disease of the nose and paranasal sinuses characterized by mucosal thickening and polyp formation¹ which are inflammatory lesions that project into the nasal airway and are typically bilateral² Chronic rhinosinsitis with nasal ployps CRSwNP affects 05 to 4 of the population worldwide ³ Symptoms include anterior or posterior rhinorrhea nasal congestion hyposmia andor facial pressure or pain that last for a duration of more than 12 weeks² The cause of the sinonasal polyps is still unknown but they may be associated with several pathological conditions ie infection allergic fungal sinusitis allergy and cystic fibrosis ⁴ Many studies were based on detection of bacterial and fungal growth in sinonasal polyps and found that preoperative bacterial culture showed growth of Staphylococcus coagulase negative CONS Staphylococcus aureus gram -ve bacteria ie Pseudomonas aeruginosa Klebsiella pneumoniae Klebsiella ozenae and Escherichia coli⁴ From fungi Aspergillus species were the most commonly recovered isolates ⁵ The initial approach of management was medical treatment Medical therapy consists of administration of intranasal or systemic steroids Other medical treatments considered the use of antibiotics leukotriene modifiers and avoidance of acetylsalicylic acid Surgical removal was performed for non-responders to medical management⁶ Functional endoscopic sinus surgery FESS is a minimally invasive technique in which sinus air cells and sinus ostia are opened under direct visualization The goal of this procedure is to restore ventilation and normal functions⁷
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None