PuraSinus for Post-Sinus Surgery Care
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Bioresorbable Nasal Dressing, PuraSinus, for post-sinus surgery care?
Is PuraSinus safe for use in humans?
Research on similar biodegradable materials, like NovoSorb, shows they are generally safe, with minimal harmful effects on human cells and no toxic effects in animal studies. These materials are used in medical applications without causing significant side effects, suggesting a good safety profile.678910
How is the PuraSinus treatment different from other post-sinus surgery treatments?
PuraSinus may be unique in its approach to post-sinus surgery care by potentially using a novel combination of materials or drugs, similar to how other treatments use absorbable nasal packings with added medications like steroids or antibiotics to improve healing and reduce complications. This could offer advantages in comfort and effectiveness compared to traditional removable nasal packings.111121314
What is the purpose of this trial?
This trial tests PuraSinus, a new gel used after sinus surgery to help the nose heal better. It aims to make recovery more comfortable by stopping bleeding, reducing inflammation, and preventing scarring in patients who have had sinus surgery.
Eligibility Criteria
This trial is for adults over 18 with chronic sinusitis who need and agree to bilateral endoscopic sinus surgery (ESS). They must meet specific criteria based on the American Academy of Otolaryngology guidelines. Those allergic to shellfish, undergoing chemotherapy/immunotherapy, with immune deficiencies or coagulation disorders, or in another clinical trial can't participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Placement of PuraSinus or bioresorbable nasal dressing in ethmoid cavity following endoscopic sinus surgery
Postoperative Debridement
Postoperative endoscopic debridement of the ethmoid cavities performed bilaterally
Follow-up
Participants are monitored for safety and effectiveness after treatment with endoscopic examinations
Treatment Details
Interventions
- Bioresorbable Nasal Dressing
- PuraSinus
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Southern California
Lead Sponsor
Northwestern University
Collaborator