PuraSinus for Post-Sinus Surgery Care

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Immune deficiency, Chemotherapy, Coagulation disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 week

30 Participants Needed

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?

Research shows that using absorbable nasal dressings, like PuraSinus, after sinus surgery can improve healing and reduce complications. Studies on similar treatments have found that they help with wound healing and patient comfort by reducing inflammation and promoting recovery. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 11 12 13 14}

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

You have been diagnosed with a condition called CRS according to specific medical guidelines.

I have agreed to sinus surgery for both sides of my nose due to ethmoid disease.

Exclusion Criteria

I have a blood clotting disorder.

You have an allergy to shellfish.

I am currently receiving chemotherapy or immunotherapy for another condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Placement of PuraSinus or bioresorbable nasal dressing in ethmoid cavity following endoscopic sinus surgery

1 week

1 visit (in-person)

Postoperative Debridement

Postoperative endoscopic debridement of the ethmoid cavities performed bilaterally

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with endoscopic examinations

12 weeks

3 visits (in-person) at weeks 1, 4, and 12

Treatment Details

Interventions

• Bioresorbable Nasal Dressing
• PuraSinus

Trial Overview The study compares PuraSinus, a new hydrogel designed to reduce bleeding and discomfort after ESS, against standard bioresorbable nasal dressings. It's a randomized controlled trial focusing on patient comfort during postoperative care.

Participant Groups

Group I: PuraSinus Experimental Treatment 1 Intervention

Placement of PuraSinus in ethmoid cavity following ESS

Group II: Bioresorbable Nasal Dressing Active Control 1 Intervention

Placement of bioresorbable nasal dressing (PosiSep X) in ethmoid cavity following ESS

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Findings from Research

The study found that three variants of NovoSorb, a biodegradable polyurethane, are biocompatible and safe for use as dermal scaffolds, showing minimal cytotoxic effects on human skin cells and no systemic toxicity in rat models.

NovoSorb demonstrated effective integration and healing in a sheep model, providing a promising foundation for a two-stage burn treatment strategy that stabilizes wounds and supports skin regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a novel biodegradable polymer for the generation of a dermal matrix. Li, A., Dearman, BL., Crompton, KE., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Triamcinolone-impregnated nasal dressing following endoscopic sinus surgery: a randomized, double-blind, placebo-controlled study. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Post-FESS middle meatal dressings: avoiding the inevitable? [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of topically applied biomaterials on paranasal sinus mucosal healing. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Biocompatibility and pharmacokinetics of fluticasone-eluting sinus implant in a rabbit model. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Advances in Absorbable Biomaterials and Nasal Packing. [2018]

6. England pubmed.ncbi.nlm.nih.gov

A comparison of the in vivo antibacterial effects of 'OpSite', 'Tegaderm' and 'Ensure' dressings. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Evaluation of a novel biodegradable polymer for the generation of a dermal matrix. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Polyurethane and silver sulfadiazene dressings in treatment of partial-thickness burns and abrasions. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Polyurethane-biomacromolecule combined foam dressing containing asiaticoside: fabrication, characterization and clinical efficacy for traumatic dermal wound treatment. [2020]

10. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Local management of purulent wounds with wound dressings]. [2022]

11. Poland pubmed.ncbi.nlm.nih.gov

Evaluation of fully biodegradable nasal packings in functional endoscopic sinus surgery – a multi-centre study. [2017]

12. United States pubmed.ncbi.nlm.nih.gov

Posisep Versus PureRegen Gel for Post ESS Nasal Packing - A Randomized Blinded Prospective Study. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Advances in absorbable biomaterials and nasal packing. [2014]

14. United States pubmed.ncbi.nlm.nih.gov

Bioabsorbable dressing impregnated with betamethasone and ciprofloxacin after endoscopic sinus surgery: A randomized, double-blind, placebo-controlled study. [2021]