Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:15 AM
Study NCT ID:
NCT07383402
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-03
First Post:
2026-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-Sinus Povidone-Iodine and Budesonide After Endoscopic Sinus Surgery for Chronic Rhinosinusitis
Sponsor:
Amin Javer
Organization:
Study Overview
Official Title:
The Efficacy of Intra-sinus Povidone-iodine/Budesonide Gel Forming Suspension Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis: a Randomized, Double Blind, Placebo-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PVP-I
Brief Summary:
Endoscopic sinus surgery (ESS) is commonly performed in patients with chronic rhinosinusitis (CRS) to improve sinus drainage and allow better delivery of topical therapies after surgery. Despite surgery, postoperative inflammation can persist and negatively affect healing and outcomes.
This randomized, double-blind, placebo-controlled clinical trial will evaluate whether intra-sinus administration of a gel-forming suspension containing povidone-iodine and budesonide improves postoperative endoscopic outcomes of the sinus cavities three months following ESS, compared with placebo.
This randomized, double-blind, placebo-controlled clinical trial will evaluate whether intra-sinus administration of a gel-forming suspension containing povidone-iodine and budesonide improves postoperative endoscopic outcomes of the sinus cavities three months following ESS, compared with placebo.
Detailed Description:
Chronic rhinosinusitis (CRS) is a chronic inflammatory condition that can significantly impact quality of life. Endoscopic sinus surgery (ESS) is performed in patients with CRS who do not respond adequately to medical therapy, with the goals of improving sinus drainage, reducing disease burden, and facilitating postoperative topical treatment delivery. However, postoperative inflammation and impaired mucosal healing may persist despite surgery and standard postoperative care.
Povidone-iodine (PVP-I) has broad antimicrobial and anti-inflammatory properties, while budesonide is a corticosteroid commonly used intranasally to reduce sinonasal inflammation. Although both agents are individually used in sinonasal care, the efficacy and safety of their combined intra-sinus administration in a gel-forming suspension following ESS have not been well established.
This randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of an intra-sinus gel-forming suspension containing PVP-I and budesonide administered at the time of ESS in adult patients with CRS. Participants will be randomized to receive either the investigational gel-forming suspension or a placebo gel following completion of surgery.
Participants will be followed postoperatively according to standard clinical care. The primary outcome will assess endoscopic appearance of the sinus cavities three months following ESS using a validated endoscopic scoring system. Secondary outcomes will evaluate postoperative sinonasal symptoms, mucosal healing, and treatment-related adverse events.
The results of this study will help determine whether intra-sinus delivery of a combined PVP-I and budesonide gel-forming suspension improves postoperative endoscopic outcomes and supports its use as an adjunctive therapy following ESS in patients with CRS.
Povidone-iodine (PVP-I) has broad antimicrobial and anti-inflammatory properties, while budesonide is a corticosteroid commonly used intranasally to reduce sinonasal inflammation. Although both agents are individually used in sinonasal care, the efficacy and safety of their combined intra-sinus administration in a gel-forming suspension following ESS have not been well established.
This randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of an intra-sinus gel-forming suspension containing PVP-I and budesonide administered at the time of ESS in adult patients with CRS. Participants will be randomized to receive either the investigational gel-forming suspension or a placebo gel following completion of surgery.
Participants will be followed postoperatively according to standard clinical care. The primary outcome will assess endoscopic appearance of the sinus cavities three months following ESS using a validated endoscopic scoring system. Secondary outcomes will evaluate postoperative sinonasal symptoms, mucosal healing, and treatment-related adverse events.
The results of this study will help determine whether intra-sinus delivery of a combined PVP-I and budesonide gel-forming suspension improves postoperative endoscopic outcomes and supports its use as an adjunctive therapy following ESS in patients with CRS.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: