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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week after surgery
Awards & highlights

Study Summary

This trial will compare the use of PuraSinus to standard care (normal saline) in sinonasal surgery patients during postoperative debridements. The primary outcome is patient comfort during the debridement procedure, as assessed by a visual analog scale.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain during debridement
Secondary outcome measures
Adhesions
Bleeding
Debridement
+3 more

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

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
905 Previous Clinical Trials
1,596,288 Total Patients Enrolled
Northwestern UniversityOTHER
1,585 Previous Clinical Trials
917,201 Total Patients Enrolled
3 Trials studying Chronic Sinusitis
226 Patients Enrolled for Chronic Sinusitis

Media Library

PuraSinus Clinical Trial Eligibility Overview. Trial Name: NCT04970966 — N/A
Chronic Sinusitis Research Study Groups: PuraSinus, Bioresorbable Nasal Dressing
Chronic Sinusitis Clinical Trial 2023: PuraSinus Highlights & Side Effects. Trial Name: NCT04970966 — N/A
PuraSinus 2023 Treatment Timeline for Medical Study. Trial Name: NCT04970966 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How extensive is the current involvement with this medical experiment?

"Affirmative. According to clinicaltrials.gov's records, this study is still open for enrollment as of January 27th 2022 since its inaugural posting on the 1st of January 2021. 30 participants are sought from a single medical site."

Answered by AI

Is there an ongoing recruitment of participants for this clinical experiment?

"According to the information housed on clinicaltrials.gov, this trial is currently seeking participants. The protocol was first uploaded on January 1st 2022 and last modified on January 27th 2022."

Answered by AI

Who else is applying?

What site did they apply to?
Keck Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I had sinus surgery many years ago. After being in hospital for COVID (Huntington Hospital) my respiratory therapist said i should go to an ear nose throat doctor.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Efficacy of PuraSinus Versus Bioresorbable Nasal Dressings
Kevin Hur 2022. "Efficacy of PuraSinus Versus Bioresorbable Nasal Dressings". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04970966.
~9 spots leftby Apr 2025
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