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Hydrogel

RADA16 Hydrogel for Post-Skull Base Surgery Recovery

N/A

Waitlist Available

Research Sponsored by Indiana University

Eligibility Criteria Checklist

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

Must have

Patient is undergoing endoscopic endonasal approach for the management of a skull base tumor or cerebrospinal fluid leak. Nasoseptal Flap must be harvested.

Patient is 18 years of age or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week, 4 weeks, and 12 weeks following surgery.

Awards & highlights

Study Summary

This trial studies how Puragel can speed up healing and reduce complications after endoscopic skull base surgery.

Who is the study for?

This trial is for adults over 18 who need surgery through both nostrils to reach the skull base, either for a tumor or cerebrospinal fluid leak. They must have a nasoseptal flap harvested during surgery. It's not for those with sinus disease seen on CT scans, previous nasal surgeries or radiation treatments, or known blood clotting or immune problems.Check my eligibility

What is being tested?

The study tests PuraGel (RADA16 hydrogel) against traditional non-absorbable packing in healing after endoscopic skull base surgery. The goal is to see if PuraGel can speed up recovery and reduce complications related to the nose and sinuses post-surgery.See study design

What are the potential side effects?

While specific side effects are not listed here, potential risks may include reactions at the application site of PuraGel, such as irritation, infection, or delayed healing compared to standard treatment.

Eligibility Criteria

Inclusion Criteria

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

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I am having surgery through my nose for a skull base tumor or CSF leak, and a part of my nasal septum will be used in the surgery.

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I am 18 years old or older.

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I am having surgery through both nostrils to reach the base of my skull.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week, 4 weeks, and 12 weeks following surgery.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week, 4 weeks, and 12 weeks following surgery.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week, 4 weeks, and 12 weeks following 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

Change in Modified Lund-Kennedy nasal endoscopy score

Secondary outcome measures

Endoscopic grading of mucosalization

Patient-reported pain

subjective QOL score

Trial Design

2Treatment groups

Active Control

Group I: PuraGel (RADA16) HydrogelActive Control1 Intervention

Participant will have PuraGel (RADA16) Hydrogel applied to the nasoseptal flap harvest site following endoscopic skull base surgery

Group II: Non-absorbable Packing (Silastic Splint)Active Control1 Intervention

Participant will have a silastic splint (Non-Absorbable Packing) applied to the nasoseptal flap harvest site following endoscopic skull base surgery with no additional packing or agent

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

983,131 Total Patients Enrolled

3-D Matrix Medical TechnologyUNKNOWN

1 Previous Clinical Trials

200 Total Patients Enrolled

Media Library

PuraGel (RADA16) Hydrogel (Hydrogel) Clinical Trial Eligibility Overview. Trial Name: NCT05898074 — N/A

Skull Base Tumors Research Study Groups: PuraGel (RADA16) Hydrogel, Non-absorbable Packing (Silastic Splint)

Skull Base Tumors Clinical Trial 2023: PuraGel (RADA16) Hydrogel Highlights & Side Effects. Trial Name: NCT05898074 — N/A

PuraGel (RADA16) Hydrogel (Hydrogel) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05898074 — N/A

Frequently Asked Questions

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

Is this medical study recruiting participants at present?

"According to the clinicaltrials.gov database, enrollment for this trial has concluded and was last updated on June 6th 2023. However, 102 other studies are presently recruiting patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

Satyan B. Sreenath 2023. "Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05898074.

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