What side effects are associated with this type of intervention?

Common treatments for skull base tumors include surgery, radiation therapy, and chemotherapy. Surgery can lead to complications such as infection, cerebrospinal fluid leaks, and damage to surrounding tissues. Radiation therapy may cause fatigue, skin irritation, and potential neurological deficits due to damage to nearby brain structures. Chemotherapy can result in systemic side effects like nausea, vomiting, hair loss, and increased risk of infection. PuraGel (RADA16 polypeptide hydrogel) is being studied to promote post-operative healing and re-mucosalization, potentially reducing some of these complications.

What prior FDA approvals exist?

FDA approvals for the treatment of skull base tumors have primarily focused on surgical interventions, radiation therapy, and chemotherapy. While specific FDA-approved treatments that promote tissue healing and re-mucosalization like PuraGel (RADA16 polypeptide hydrogel) are not explicitly mentioned, various hydrogels and tissue engineering products have been explored in clinical settings to aid post-operative healing. These include products like Floseal and Surgiflo, which are used to control bleeding and support tissue regeneration. Additionally, advancements in biomaterials and regenerative medicine continue to be investigated to improve outcomes in skull base surgery.

What other types of research exist?

One promising alternative to PuraGel for promoting tissue healing and re-mucosalization in Skull Base Tumors patients is platelet-rich plasma (PRP). PRP contains growth factors that aid in cell proliferation and differentiation, and it has anti-inflammatory properties. Clinical trials have shown PRP to be effective in inducing tissue regeneration and reducing symptoms such as burning or itching. Further studies are needed to validate these findings, but PRP represents a novel and promising option for patients undergoing treatment in 2024.

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Hydrogel

RADA16 Hydrogel for Post-Skull Base Surgery Recovery

N/A

Recruiting

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

Must not have

Patient has evidence of radiographic baseline sinus disease consistent with acute or chronic rhinosinusitis (including nasal polyposis, prior septal perforation) on pre-operative CT sinus

Patient has had prior sinonasal surgery or has undergone sinonasal radiation treatment

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing PuraGel, a protein-based gel, to help patients heal better after endoscopic skull base surgery. The gel supports new tissue growth and protects it, aiming to reduce complications like scarring and crusting.

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.

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.

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

Select...

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.

Select...

I am 18 years old or older.

Select...

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

Exclusion Criteria

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

Select...

My CT scan shows I have sinus disease, like chronic rhinosinusitis or nasal polyps.

Select...

I have had surgery or radiation treatment for my sinuses.

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

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

Primary study objectives

Change in Modified Lund-Kennedy nasal endoscopy score

Secondary study objectives

Endoscopic grading of mucosalization

Patient-reported pain

subjective QOL score

Awards & Highlights

No Placebo-Only Group

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

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 / 5Eligibility 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 skull base tumors include surgery, radiation therapy, and chemoradiotherapy. These treatments aim to remove or reduce the tumor while preserving surrounding critical structures. Surgery physically removes the tumor, radiation therapy uses high-energy rays to destroy cancer cells, and chemoradiotherapy combines chemotherapy with radiation to enhance the effectiveness of both. Treatments like PuraGel (RADA16 polypeptide hydrogel) are particularly important as they promote tissue healing and re-mucosalization post-surgery, reducing complications and improving recovery. This is crucial for skull base tumor patients due to the complex anatomy and critical functions of the skull base region.

Multi-responsive nanofibers composite gel for local drug delivery to inhibit recurrence of glioma after operation.In vitro testing to a panel of potential chemotherapeutics and current concepts of chemotherapy in benign meningiomas.Development of patient-derived xenograft models from a spontaneously immortal low-grade meningioma cell line, KCI-MENG1.