RADA16 Hydrogel for Post-Skull Base Surgery Recovery

Overseen By Satyan Sreenath, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Sinus disease, Prior sinonasal surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests PuraGel (RADA16) Hydrogel to determine if it speeds up healing after skull base surgery. Researchers aim to assess its effectiveness in improving healing and reducing issues such as nasal and sinus discomfort. Participants will receive either PuraGel or a standard splint for comparison. Individuals who have undergone or are about to undergo surgery for a skull base tumor or fluid leak using a specific nasal approach may qualify for this trial. As an unphased trial, it provides a unique opportunity to contribute to innovative research that could enhance post-surgical recovery.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

What prior data suggests that PuraGel (RADA16) Hydrogel is safe for post-surgical recovery?

In previous studies, RADA16, the main ingredient in PuraGel, showed promise in helping wounds heal and stopping bleeding. The FDA has already approved it for these uses. Research shows that patients who used RADA16 experienced less bleeding after surgery. It is considered safe and easy to use. So far, no major safety issues have been reported with its use, suggesting that PuraGel is generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike the standard of care for post-skull base surgery recovery, which typically involves non-absorbable packing like Silastic splints, PuraGel (RADA16) Hydrogel offers a unique approach. This hydrogel is applied directly to the surgical site and has the potential to enhance healing by providing a supportive and bio-compatible environment. Researchers are excited about PuraGel because it could reduce complications and improve comfort for patients, offering a more advanced and potentially effective alternative to traditional packing methods.

What evidence suggests that PuraGel (RADA16) Hydrogel is effective for post-skull base surgery recovery?

Research has shown that PuraGel, a special type of gel, helps wounds heal faster. In one study, wounds treated with this gel closed more quickly and showed clear improvement. Another study found that it reduced bleeding after nose surgery, known as epistaxis. This trial will compare PuraGel with a Non-absorbable Packing (Silastic Splint) for post-surgery recovery. PuraGel effectively speeds up healing and stops bleeding. Overall, these findings suggest that PuraGel could help patients recover more quickly after certain types of skull surgery. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

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

Exclusion Criteria

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

I have had surgery or radiation treatment for my sinuses.

You have a known blood clotting problem or a weak immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Immediate Postoperative Care

Participants undergo endoscopic skull base surgery with application of PuraGel or non-absorbable packing

1 week

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for wound healing, adhesion formations, and sinonasal morbidity using various scoring systems

12 weeks

3 visits (in-person) at 1 week, 4 weeks, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PuraGel (RADA16) Hydrogel

Trial Overview 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.

How Is the Trial Designed?

Group I: PuraGel (RADA16) Hydrogel Active Control 1 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 Control 1 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

PuraGel (RADA16) Hydrogel is already approved in European Union, United States for the following indications:

Approved in European Union as PuraGel for:

• Hemostasis during surgical procedures
• Prevention of adhesion formation

Approved in United States as PuraGel for:

• Hemostasis during nasal surgery and trauma repair
• Prevention of adhesion formation
• Adjunct to wound healing

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

3-D Matrix Medical Technology

Collaborator

Trials

3

Recruited

240+

3-D Matrix UK Ltd.

Industry Sponsor

Published Research Related to This Trial

In a study involving 30 sheep undergoing endoscopic sinus surgery, the RADA16 hydrogel significantly reduced postoperative synechiae formation compared to Gelatin-thrombin and control treatments, with a 91% reduction at 2 weeks and complete absence at 6 weeks.

Both RADA16 and Gelatin-thrombin improved intra-operative hemostasis times, but only RADA16 demonstrated enhanced wound healing, as indicated by lower histopathology scores related to fibrosis and angiogenesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-assembling RADA16 peptide hydrogel supports hemostasis, synechiae reduction, and wound healing in a sheep model of endoscopic nasal surgery. Lee, MF., Ananda, A.[2023]

RADA16 is a highly stable amphiphilic polypeptide that forms a 3D nanofiber hydrogel scaffold, demonstrating excellent biocompatibility and low immunogenicity, making it suitable for various biomedical applications.

The unique structure of RADA16 promotes cell proliferation and differentiation, and modifications to its ends with functional peptides enhance its capabilities, leading to applications in tissue repair, 3D cell culture, and drug delivery systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a RADA16-based self-assembling peptide nanofiber scaffold for biomedical applications. Wang, R., Wang, Z., Guo, Y., et al.[2020]

The synthetic glycopeptide hydrogel (GRgel) combined with a 3D-printed scaffold significantly enhanced the growth and bone-forming ability of stem cells, promoting effective healing in large cranial bone defects in rats.

In a rat model, the GRgel scaffold led to an impressive 83.3% bone area regeneration after 12 weeks, creating a favorable healing environment by increasing anti-inflammatory macrophages and blood vessel formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomimetic glycopeptide hydrogel coated PCL/nHA scaffold for enhanced cranial bone regeneration via macrophage M2 polarization-induced osteo-immunomodulation. Wang, Y., Wang, J., Gao, R., et al.[2022]

RADA16 is a synthetic peptide that forms a stable hydrogel upon exposure to physiological pH, making it an effective topical hemostatic agent for controlling bleeding during surgeries, with applications in cardiovascular, gastrointestinal, and otorhinolaryngological procedures.

The hydrogel's properties, such as transparency and ease of application through narrow nozzles, allow for clear visualization during surgery and safe use near sensitive tissues, while also avoiding risks of contamination associated with natural hemostatic agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Use of the Self-Assembling Peptide RADA16: A Review of Current and Future Trends in Biomedicine. Sankar, S., O'Neill, K., Bagot D'Arc, M., et al.[2021]

Biodegradable thiol-acrylate hydrogels were tested as carriers for stem cells to promote cranial bone regeneration in New Zealand White Rabbits, showing that 5 wt% PEGDA hydrogels had better metabolic activity than 15 wt% PEGDA hydrogels.

The study found that 15 wt% PEGDA hydrogels enhanced alkaline phosphatase activity in stem cells, indicating potential for improved bone formation, while 5 wt% PEGDA hydrogels showed less residual gel after 6 weeks, suggesting better degradation and integration with bone tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photoencapsulated-mesenchymal stromal cells in biodegradable thiol-acrylate hydrogels enhance regeneration of craniofacial bone tissue defects. Aghali, A., Arman, HE.[2021]

The study found that the self-assembly of RADA peptides into hydrogels is dependent on the length of the peptide chain, with shorter chains (N less than 3) failing to form spontaneous assemblies.

Using various biophysical techniques, the research confirmed that longer RADA peptides (with 4 to 16 amino acids) are necessary for effective aggregation and self-assembly, which is crucial for their application in creating three-dimensional microenvironments for cell culture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Directive Effect of Chain Length in Modulating Peptide Nano-assemblies. Pandey, G., Das, PP., Ramakrishnan, V.[2021]

The study tested a new tissue engineering approach using EH-PEG hydrogels for repairing orbital floor injuries in rabbits, showing that these hydrogels can effectively support bone growth when loaded with bone morphogenetic protein-2 (BMP-2).

Significant bone formation was observed in the group with 2.5 micrograms of BMP-2 after 28 days, indicating that the EH-PEG hydrogel is a promising method for enhancing bone repair in craniofacial injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tissue response and orbital floor regeneration using cyclic acetal hydrogels. Betz, MW., Caccamese, JF., Coletti, DP., et al.[2022]

In a study involving 25 patients aged 18 to 60 with nasal cavity and paranasal sinus issues, the use of a hydrogel-based composition after surgery significantly improved wound healing and reduced postoperative edema.

The hydrogel, made from sodium alginate, sodium hyaluronate, and dioxydin, was effective in enhancing epithelization and improving the condition of the mucous membranes following endoscopic surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The application of the hidrogel-based medicinal compositions for the targeted delivery of medications in rhino- and otosurgery]. Oltarzhevskaya, ND., Kirichenko, IM., Khar'kova, NA., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12030742/

Efficacy of RADA16-Based Self-Assembling Peptides on ... As shown in Figure S2, an overall significant enhancement of wound closure rate was observed for wounds treated with RADA16 (MD = 9.44, 95%CI: 3.62 to 15.26, p ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1549963421001283?via%3Dihub#!

Efficacy and histopathological effects of self-assembling ... Primary outcomes for the safety evaluation were the rate of general adverse events observed (epilepsy, postoperative bleeding, and death) and the severity of ...

3. ctv.veeva.com ctv.veeva.com/study/role-of-novel-rada16-hydrogel-in-endoscopic-skull-base-surgery

Role of Novel RADA16 Hydrogel in Endoscopic Skull Base ... The purpose of this study is to specifically evaluate the effectiveness of PuraGel, a RADA16 polypeptide hydrogel, in expediting post-operative ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/lary.32278?af=R

RADA‐16 Reduces Postoperative Epistaxis After Inferior ... RADA-16 is believed to improve wound healing and hemostasis. In our study, we found that patients receiving RADA-16 are less likely to experience epistaxis ...

5. ashpublications.org ashpublications.org/bloodvth/article-pdf/doi/10.1016/j.bvth.2025.100098/2404497/bvth_vth-2025-000349-main.pdf

Nasal RADA16 Hydrogel Application Decreases Epistaxis ... RADA16 is a self-assembling peptide hydrogel approved by the FDA for hemostasis and wound healing. In this cohort study, we assessed the effectiveness of nasal ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12519286/

Nasal RADA16 hydrogel application decreases epistaxis ... Our experience demonstrates that RADA16 can be considered as a safe epistaxis treatment modality for HHT that is easy to apply and does not require the ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05898074/role-of-novel-rada16-hydrogel-in-endoscopic-skull-base-surgery

Role of Novel RADA16 Hydrogel in Endoscopic Skull Base ... The purpose of this study is to specifically evaluate the effectiveness of PuraGel, a RADA16 polypeptide hydrogel, in expediting ...

8. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/507576

Role of Novel RADA16 Hydrogel in Endoscopic Skull Base ... The purpose of this study is to specifically evaluate the effectiveness of PuraGel, a RADA16 polypeptide hydrogel, in expediting ...