What side effects are associated with this type of intervention?

Common treatments for chronic sinusitis, particularly those used post-endoscopic sinus surgery (ESS) like topical haemostatic agents, aim to enhance mucosal wound healing and reduce bleeding and discomfort. Known side effects of these treatments can include local irritation, transient pain, and discomfort during application. Some patients may experience mild to moderate bleeding, which is generally self-limiting. Additionally, there can be a risk of infection if the nasal cavity is not properly maintained. Overall, these treatments are designed to minimize inflammation and scarring, but patient experiences can vary.

What prior FDA approvals exist?

FDA-approved treatments for Chronic Sinusitis primarily include corticosteroid nasal sprays, saline nasal irrigation, and antibiotics for bacterial infections. While specific topical haemostatic agents like PuraSinus, which utilize nanotechnologies to enhance mucosal wound healing and reduce bleeding, are not widely documented in FDA approvals, similar treatments focus on reducing inflammation and promoting healing. For instance, intranasal corticosteroids are commonly used to reduce inflammation and improve sinus drainage, indirectly aiding in mucosal healing. Additionally, bioresorbable nasal dressings and stents are sometimes used post-surgery to support healing and reduce scar tissue formation.

What other types of research exist?

Promising alternatives to PuraSinus for chronic sinusitis patients include bioresorbable nasal dressings, which help in reducing inflammation and scarring post-surgery, and novel topical agents like chitosan-based gels that promote wound healing and hemostasis. Additionally, advancements in balloon sinuplasty techniques and drug-eluting stents that deliver anti-inflammatory medications directly to the sinus tissues are also noteworthy.

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PuraSinus for Post-Sinus Surgery Care

N/A

Waitlist Available

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient is 18 years of age or older

Patient has a clinical indication for and has consented for primary or revision bilateral ESS and had evidence of ethmoid disease bilaterally (Lund-Mackay score at least 1 on each side)

Must not have

Patient has a known coagulation disorder

Patient has concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease (e.g. cancer, HIV, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week after surgery

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not detailed but may include typical reactions associated with topical agents used in postoperative care such as local irritation or an allergic reaction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a blood clotting disorder.

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I am currently receiving chemotherapy or immunotherapy for another condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain during debridement

Secondary study objectives

Adhesions

Bleeding

Debridement

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PuraSinusExperimental Treatment1 Intervention

Placement of PuraSinus in ethmoid cavity following ESS

Group II: Bioresorbable Nasal DressingActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PuraSinus

2022

N/A

~30

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Chronic Sinusitis include topical corticosteroids, saline irrigation, and novel agents like PuraSinus. Topical corticosteroids reduce inflammation by inhibiting cytokine production, which helps decrease mucosal swelling and improve sinus drainage. Saline irrigation helps clear mucus and allergens, reducing the inflammatory load and facilitating better medication access. PuraSinus, a topical haemostatic agent based on nanotechnologies, enhances mucosal wound healing and reduces bleeding and discomfort during postoperative care. These treatments are crucial for Chronic Sinusitis patients as they address inflammation, promote healing, and improve overall sinus function, thereby reducing symptoms and preventing complications.

Sinus implants for chronic rhinosinusitis: technology evaluation.Topical therapies in the management of chronic rhinosinusitis: an evidence-based review with recommendations.