Evaluating a new hydrogel for healing after skull base surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Indiana University
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Study coordinator: Satyan Sreenath, MD
• Email: ssreenat@iu.edu
• Phone: (317) 944-0457

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.