Intra-Sinus Povidone-Iodine and Budesonide After Endoscopic Sinus Surgery for Chronic Rhinosinusitis

ConditionChronic Rhinosinusitis (CRS)

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age19+

SponsorAmin Javer

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Povidone-Iodine and Budesonide Gel-Forming Suspension
Drug
A gel-forming suspension containing povidone-iodine and budesonide administered intra-sinus at the completion of endoscopic sinus surgery, intended to reduce postoperative inflammation and improve sinus cavity healing.
Placebo Gel-Forming Suspension
Drug
A gel-forming suspension without povidone-iodine or budesonide administered intra-sinus at the completion of endoscopic sinus surgery.

Treatment groups

180 Participants

are divided into 2 treatment groups

Group A: Povidone-Iodine and Budesonide Gel-Forming SuspensionActive comparator 1 intervention

Group B: Placebo Gel-Forming SuspensionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Change in Modified Lund-Kennedy (MLK) Endoscopic Score

Change in the Modified Lund-Kennedy (MLK) endoscopic score comparing baseline to 12 weeks following endoscopic sinus surgery. The MLK score is a validated endoscopic scoring system assessing sinonasal inflammation, including edema and polyps, with higher scores indicating worse disease severity.

Time frame

12 weeks postoperatively

Secondary outcomes

Scar Tissue Formation

Presence and severity of postoperative scar tissue formation assessed by nasal endoscopy.

Time frame

Up to 24 weeks postoperatively

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amin Javer

Lead sponsor

St. Paul's Hospital, Canada

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: