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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new treatment, called PuraSinus, can ease recovery for individuals who have undergone sinus surgery. The researchers seek to discover if this treatment can make the healing process more comfortable and reduce the pain and bleeding often associated with post-surgery cleaning. The study will compare PuraSinus, a bioresorbable nasal dressing, to another standard treatment to assess which is more effective. Individuals who recently had sinus surgery due to chronic sinus issues and are experiencing ongoing symptoms might be suitable candidates for this trial. As an unphased trial, this study provides an opportunity to contribute to understanding how PuraSinus can enhance post-surgery recovery.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that absorbable nasal dressings like PuraSinus can aid healing and reduce complications after sinus surgery. PuraSinus, a gel applied to the surgical area, promotes healing and provides comfort.

One study found that products similar to PuraSinus can stop bleeding faster and reduce pain shortly after surgery. This suggests that PuraSinus might be well-tolerated by patients. However, limited direct clinical evidence exists specifically for PuraSinus, so this should be considered when evaluating its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PuraSinus because it offers an innovative approach to post-sinus surgery care by utilizing a bioresorbable material that can be placed directly in the ethmoid cavity. Unlike traditional nasal dressings, which may require removal and can cause discomfort, PuraSinus naturally dissolves over time, potentially leading to a more comfortable recovery process. This treatment stands out because it not only supports healing but also minimizes the need for additional procedures, making the post-operative experience smoother for patients.

What evidence suggests that this trial's treatments could be effective for post-sinus surgery care?

This trial will compare PuraSinus with a bioresorbable nasal dressing for post-sinus surgery care. Research has shown that absorbable nasal dressings like PuraSinus can aid healing and reduce complications after sinus surgery. PuraSinus, a new gel, aims to lessen bleeding and promote wound healing. Early results suggest it might enhance recovery by reducing swelling and scarring. Although direct clinical data on PuraSinus remains limited, studies on similar treatments have demonstrated positive effects on healing and patient satisfaction. Overall, PuraSinus appears promising for improving recovery after sinus surgery. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. withpower.com withpower.com/trial/phase-paranasal-sinus-diseases-10-2021-c9847

PuraSinus for Post-Sinus Surgery Care · Info for Participants Research shows that using absorbable nasal dressings, like PuraSinus, after sinus surgery can improve healing and reduce complications. Studies on similar ...

2. ctv.veeva.com ctv.veeva.com/study/efficacy-of-purasinus-versus-bioresorbable-nasal-dressings

Efficacy of PuraSinus Versus Bioresorbable Nasal Dressings The potential of PuraSinus to enhance endoscopic mucosal wound healing may play a role in optimizing patient comfort during postoperative ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33393665/

Efficacy of Absorbable Steroid-Impregnated Nasal Packing ... Steroid-impregnated nasal packing appears to have positive effects on postoperative endoscopic outcomes in CRSwNP patients undergoing FESS.

4. mdpi.com mdpi.com/2504-463X/6/2/11

Enhanced Evaluation of Bioresorbable Steroid-Releasing ... This review analyzes bioresorbable steroid-releasing implants and corticosteroid-impregnated nasal dressings, focusing on their pharmacologic mechanisms, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1808869416300039

Clinical outcome and patient satisfaction using ... The aim of this study was to compare patient satisfaction and clinical outcome associated with absorbable and non-absorbable packing after FESS.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06642116

Study Details | NCT06642116 | Evaluation of the Safety ... The objective of this study is to investigate the safety and performance of OCEAN® as an adjunct in wound healing after nasal/sinus surgery by using OCEAN® in ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5545704/

Efficacy and Safety of Guardcel Nasal Packing After ... Guardcel, a newly developed packing material, appeared to shorten the hemostasis time and reduce pain sensation at 2–3 days after surgery.

8. journals.sagepub.com journals.sagepub.com/doi/10.1177/01455613211062457

A randomized, double-blind, placebo-controlled study The results of this study revealed a significant improvement in postoperative healing and patient satisfaction after endoscopic sinus surgery ...