RADA16 Hydrogel for Post-Skull Base Surgery Recovery

Overseen By Satyan Sreenath, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Indiana University

Disqualifiers: Sinus disease, Prior sinonasal surgery, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment PuraGel (RADA16) Hydrogel for post-skull base surgery recovery?

Research on similar hydrogels, like the glycopeptide hydrogel GRgel, shows they can help bone healing by promoting cell growth and reducing inflammation, which might suggest potential benefits for PuraGel in post-surgery recovery. ^{1 2 3 4 5}

How is the treatment PuraGel (RADA16) Hydrogel unique for post-skull base surgery recovery?

PuraGel (RADA16) Hydrogel is unique because it is a self-assembling peptide that forms a stable, transparent 3D matrix similar to natural tissue structures, which helps control bleeding and supports wound healing. It can be easily applied to hard-to-reach areas, does not swell, and avoids immune reactions, making it ideal for delicate surgical sites. ^{3 5 6 7 8}

Eligibility Criteria

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 18 years old or older.

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.

Trial Timeline

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

Treatment Details

Interventions

• PuraGel (RADA16) Hydrogel (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.

Participant Groups

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

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+

Findings from Research

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 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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Tissue response and orbital floor regeneration using cyclic acetal hydrogels. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Directive Effect of Chain Length in Modulating Peptide Nano-assemblies. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Biomimetic glycopeptide hydrogel coated PCL/nHA scaffold for enhanced cranial bone regeneration via macrophage M2 polarization-induced osteo-immunomodulation. [2022]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The application of the hidrogel-based medicinal compositions for the targeted delivery of medications in rhino- and otosurgery]. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Use of the Self-Assembling Peptide RADA16: A Review of Current and Future Trends in Biomedicine. [2021]

7. Netherlands 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Design of a RADA16-based self-assembling peptide nanofiber scaffold for biomedical applications. [2020]