Clinical trial · Interventional
Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery
Novel Application of RADA16 Hydrogel in Reducing Sinonasal Morbidity After Endoscopic Skull Base Surgery
NCT05898074CI-TRIAL-00124251recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to specifically evaluate the effectiveness of PuraGel, a RADA16 polypeptide hydrogel, in expediting post-operative healing and re-mucosalization of the nasoseptal flap harvest site during endoscopic skull base surgery and the impact on patient and sinonasal morbidity.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cerebrospinal Fluid Leakage | — | UNRESOLVED | — |
| Nasal; Hypertrophy, Mucous Membrane (Septum) | — | UNRESOLVED | — |
| Skull Base Neoplasms | Skull Base Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Absorbable Packing (Silastic Splint) | Device | — | UNRESOLVED |
| PuraGel (RADA16) Hydrogel | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- PuraGel (RADA16) Hydrogel
- description
- Participant will have PuraGel (RADA16) Hydrogel applied to the nasoseptal flap harvest site following endoscopic skull base surgery
- interventionNames
- Device: PuraGel (RADA16) Hydrogel
- type
- ACTIVE_COMPARATOR
- label
- Non-absorbable Packing (Silastic Splint)
- description
- 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
- interventionNames
- Device: Non-Absorbable Packing (Silastic Splint)
Primary outcomes (1)
- measure
- Change in Modified Lund-Kennedy nasal endoscopy score
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.