RADA16 Hydrogel for Post-Skull Base Surgery Recovery
Recruiting in Palo Alto (17 mi)
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.
12345How 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.
35678Eligibility 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
Participant Groups
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.
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
PuraGel (RADA16) Hydrogel is already approved in European Union, United States, Australia for the following indications:
πͺπΊ Approved in European Union as PuraGel for:
- Hemostasis during surgical procedures
- Prevention of adhesion formation
πΊπΈ Approved in United States as PuraGel for:
- Hemostasis during nasal surgery and trauma repair
- Prevention of adhesion formation
- Adjunct to wound healing
π¦πΊ Approved in Australia as PuraGel for:
- Hemostasis during surgical procedures
- Prevention of adhesion formation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Indiana UniversityIndianapolis, IN
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Who Is Running the Clinical Trial?
Indiana UniversityLead Sponsor
3-D Matrix Medical TechnologyCollaborator
References
Photoencapsulated-mesenchymal stromal cells in biodegradable thiol-acrylate hydrogels enhance regeneration of craniofacial bone tissue defects. [2021]Aim: This study investigated biodegradable thiol-acrylate hydrogels as stem cell carriers to facilitate cranial bone regeneration. Materials & methods: Two formulations of thiol-acrylate hydrogels (5 and 15 wt% Poly[ethylene glycol]-diacrylate [PEGDA] hydrogels) were used as stem cell carriers. Bone marrow mesenchymal stromal cells and dental pulp mesenchymal stromal cells were photoencapsulated and cultured in basal or osteogenic medium 3 days before the surgery. Using New Zealand White Rabbits, four defects (5 mm diameter and 2 mm thickness) were created and hydrogel scaffolds were implanted in each rabbit cranium for 6 weeks. Results & Conclusion: AlamarBlue assay showed increasing metabolic activity levels in 5 wt% PEGDA hydrogels than 15 wt% PEGDA hydrogels. Photoencapsulated-mesenchymal stromal cells in 15 wt% PEGDA hydrogels demonstrated significantly increasing alkaline phosphatase activity levels on day 7 compared with days 1 and 3. Histological diagnosis showed 5 wt% PEGDA hydrogels resulted in lower averaged residual gel areas than 15 wt% PEGDA hydrogel specimens and control groups 6 weeks postimplantation.
Tissue response and orbital floor regeneration using cyclic acetal hydrogels. [2022]Orbital floor injuries are a common form of traumatic craniofacial injury that may not heal properly through the body's endogenous response. Reconstruction is often necessary, and an optimal method does not exist. We propose a tissue engineering approach for orbital bone repair based upon a cyclic acetal biomaterial formed from 5-ethyl-5-(hydroxymethyl)-beta,beta-dimethyl-1,3-dioxane-2-ethanol diacrylate (EHD) and poly(ethylene glycol) diacrylate (PEGDA). The EHD monomer and PEGDA polymer may be fabricated into an EH-PEG hydrogel by radical polymerization. The objectives of this work were to study (1) the tissue response to EH-PEG hydrogels in an orbital bone defect and (2) the induction of bone formation by delivery of bone morphogenetic protein-2 (BMP-2) from EH-PEG hydrogels. EH-PEG hydrogels were fabricated and implanted into an 8-mm rabbit orbital floor defect. Experimental groups included unloaded EH-PEG hydrogels, and EH-PEG hydrogels containing 0.25 microg and 2.5 microg BMP-2/implant. Results demonstrated that the unloaded hydrogel was initially bordered by a fibrin clot and then by fibrous encapsulation. BMP-2 loaded EH-PEG hydrogels, independent of concentration, were surrounded by fibroblasts at both time points. Histological analysis also demonstrated that significant bone growth was present at the 2.5 microg BMP-2/implant group at 28 days. This work demonstrates that the EH-PEG construct is a viable option for use and delivery of BMP-2 in vivo.
Directive Effect of Chain Length in Modulating Peptide Nano-assemblies. [2021]RADA-4 (Ac-RADARADARADARADA-NH2) is the most extensively studied and marketed self-assembling peptide, forming hydrogel, used to create defined threedimensional microenvironments for cell culture applications.
Biomimetic glycopeptide hydrogel coated PCL/nHA scaffold for enhanced cranial bone regeneration via macrophage M2 polarization-induced osteo-immunomodulation. [2022]The reconstruction of large cranial bone defects by bioactive materials without exogenous cells or growth factors remains a substantial clinical challenge. Here, synthetic fibrous glycopeptide hydrogel (GRgel) self-assembled by β-sheet RADA16-grafted glucomannan was designed to mimic the glycoprotein composition and the fibrillar architecture of natural extracellular matrix (ECM), which was non-covalently composited with 3D-printed polycaprolactone/nano hydroxyapatite (PCL/nHA) scaffold for cranial bone regeneration. The glycopeptide hydrogel significantly promoted the proliferation, osteogenic differentiation of bone mesenchymal stem cells (BMSCs), which was further augmented by GRgel-induced macrophage M2-phonotype polarization and the effective M2 macrophage-BMSC crosstalk. The repair of critical-size skull bone defect in rat indicated a superior efficacy of PCL/nHA@GRgel implant on bone regeneration and osseointegration, with an average bone area of 83.3% throughout the defect location at 12 weeks post treatment. Furthermore, the osteo-immunomodulatory GRgel induced a reparative microenvironment similar with that in normal cranium, as characterized by an increased percentage of anti-inflammatory M2 macrophages and osteoblasts, and high-level vascularization. Collectively, the composite scaffold developed here with macrophage polarization-mediated osteo-immunomodulation may represent a promising implant for expediting in situ bone regeneration by providing biochemical and osteoinductive cues at the injured tissue.
[The application of the hidrogel-based medicinal compositions for the targeted delivery of medications in rhino- and otosurgery]. [2019]The objective of the present study was the analysis of the application of the hydrogel-based medicinal compositions for the treatment of the patients presenting with pathological changes in the nasal cavity and paranasal sinuses during the postoperative period. A total of 25 patients at the age from 18 to 60 years with the diseases of the nasal cavity and paranasal sinuses were available for the examination including 12 ones with polypous polysinusitis and 13 patients having benign neoplasms in the nasal cavity, paranasal sinuses, and the base of the skull. All these patients underwent endoscopic endonasal polysinusotomy. After the surgical intervention was completed, the postoperative cavities were filled up with a gel containing sodium alginate, sodium hyaluronate, and dioxydin. This procedure was followed by the tamponade with the use of the silicone oil tampons in conformity with the standard method. The application of the polyfunctional depot-materials in the combination with the physiotherapeutic treatment modalities made it possible to accelerate the wound healing processes including epithelization, changes in the mucous membrane of the paranasal sinuses, and the reduction of the postoperative oedema.
Clinical Use of the Self-Assembling Peptide RADA16: A Review of Current and Future Trends in Biomedicine. [2021]RADA16 is a synthetic peptide that exists as a viscous solution in an acidic formulation. In an acidic aqueous environment, the peptides spontaneously self-assemble into β-sheet nanofibers. Upon exposure and buffering of RADA16 solution to the physiological pH of biological fluids such as blood, interstitial fluid and lymph, the nanofibers begin physically crosslinking within seconds into a stable interwoven transparent hydrogel 3-D matrix. The RADA16 nanofiber hydrogel structure closely resembles the 3-dimensional architecture of native extracellular matrices. These properties make RADA16 formulations ideal topical hemostatic agents for controlling bleeding during surgery and to prevent post-operative rebleeding. A commercial RADA16 formulation is currently used for hemostasis in cardiovascular, gastrointestinal, and otorhinolaryngological surgical procedures, and studies are underway to investigate its use in wound healing and adhesion reduction. Straightforward application of viscous RADA16 into areas that are not easily accessible circumvents technical challenges in difficult-to-reach bleeding sites. The transparent hydrogel allows clear visualization of the surgical field and facilitates suture line assessment and revision. The shear-thinning and thixotropic properties of RADA16 allow its easy application through a narrow nozzle such as an endoscopic catheter. RADA16 hydrogels can fill tissue voids and do not swell so can be safely used in close proximity to pressure-sensitive tissues and in enclosed non-expandable regions. By definition, the synthetic peptide avoids potential microbiological contamination and immune responses that may occur with animal-, plant-, or mineral-derived topical hemostats. In vitro experiments, animal studies, and recent clinical experiences suggest that RADA16 nanofibrous hydrogels can act as surrogate extracellular matrices that support cellular behavior and interactions essential for wound healing and for tissue regenerative applications. In the future, the unique nature of RADA16 may also allow us to use it as a depot for precisely regulated drug and biopharmaceutical delivery.
Self-assembling RADA16 peptide hydrogel supports hemostasis, synechiae reduction, and wound healing in a sheep model of endoscopic nasal surgery. [2023]Complications of endoscopic sinus/nasal turbinate surgery include postoperative hemorrhage, synechiae formation, and poor wound healing. Our primary objectives were to evaluate whether a topical hydrogel based on self-assembling RADA16 peptides: i) reduces bleeding and synechiae formation, and ii) supports wound healing, using a sheep nasal surgery model.
Design of a RADA16-based self-assembling peptide nanofiber scaffold for biomedical applications. [2020]RADA16 (RADARADARADARADA) is an amphiphilic polypeptide composed of 16 amino acids, which is composed of alternating positively charged arginine (R), hydrophobic alanine (A) and negatively charged aspartic acid (D) that repeat periodically throughout the composition. This structure allows RADA16 to form an extremely stable and highly ordered Ξ²-sheet structure by noncovalent bonding (ionic bonds, hydrogen bonds, hydrophobic action, Ο-Ο bonds, etc.). Moreover, it can form a three-dimensional (3D) nanofiber hydrogel scaffold in neutral pH with water content higher than 99% and with a physiological saline solution, having excellent biocompatibility and low immunogenicity, etc. Its degradation products are amino acids, which can reduce the possibility of an inflammatory reaction and have little effect on the normal healing process of damaged tissue. In addition, the special 3D structure of RADA16 facilitates the proliferation and differentiation of cells, making it widely used in cell culture scaffolds. Subsequent studies have found that the C-terminus or N-terminus of RADA16 is modified by a specific functional peptide, which not only retains the original function of RADA16 but also gives the RADA16 self-assembling hydrogel a more powerful function. In recent years, RADA16 and RADA16-based fusion peptides have been applied in biomedical fields, such as 3D cell culture, tissue repair, rapid hemostasis, and delivery systems, which have broad prospects. This review focuses on recent research and applications of RADA16 and RADA16-based self-assembling peptide nanofiber scaffold (SAPNS) in biomedicine.