Evaluating a new hydrogel for healing after skull base surgery
Novel Application of RADA16 Hydrogel in Reducing Sinonasal Morbidity After Endoscopic Skull Base Surgery
NA · Indiana University · NCT05898074
This study is testing a new gel to see if it helps people heal better after skull base surgery compared to regular packing methods.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT05898074 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of PuraGel, a RADA16 polypeptide hydrogel, in enhancing post-operative healing and re-mucosalization at the nasoseptal flap harvest site during endoscopic skull base surgery. The research will compare the hydrogel's performance against traditional non-absorbable packing methods to determine its impact on sinonasal morbidity, including issues like crusting and bleeding. By providing a synthetic matrix that promotes healing and reduces scarring, this study seeks to fill a gap in existing knowledge regarding postoperative care in skull base surgeries.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for endoscopic surgery to manage a skull base tumor or cerebrospinal fluid leak and require a nasoseptal flap harvest.
Not a fit: Patients with existing sinus disease, prior sinonasal surgeries, or coagulation disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes and reduce complications for patients undergoing endoscopic skull base surgery.
How similar studies have performed: While there have been studies on various agents in sinonasal surgeries, this specific application of PuraGel in endoscopic skull base surgery is novel and has not been previously evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient is 18 years of age or older * 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 undergoing surgery via bi-nostril approach requiring bilateral surgical dissection of the nasal cavity in approach to the skull base Exclusion Criteria: * 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 * Patient has a known coagulation disorder or immune deficiency.
Where this trial is running
Indianapolis, Indiana
- Indiana University — Indianapolis, Indiana, United States (RECRUITING)
Study contacts
- Study coordinator: Satyan Sreenath, MD
- Email: ssreenat@iu.edu
- Phone: (317) 944-0457
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Skull Base Neoplasms, Cerebrospinal Fluid Leakage, Nasal, Hypertrophy, Mucous Membrane, Nasoseptal Flap Harvest, Sinonasal Morbidity, Extracellular Matrix, Endoscopic Skull Base Surgery