Clinical Trial: Analysis of Hemostatic Agents Compared to Physiologic Hemostasis

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Analysis of Hemostatic Agents Compared to Physiologic Hemostasis

Brief Summary: This study is a prospective comparison between absorbable hemostatic agents as a group and the body's natural hemostatic ability without aid of therapy in patients undergoing bilateral sinus surgery with or without septoplasty.

Detailed Summary: The purpose of this study is to evaluate the efficacy of absorbable hemostatic agents in comparison with physiologic hemostasis after endoscopic sinus surgery. The investigators aim to determine the relative efficacy of hemostatic agents to halt epistaxis and compare this with the degree of epistaxis observed without therapy and evaluate objective healing parameters.
Sponsor: St. Louis University

Current Primary Outcome: Number of participants with superior healing qualities after use of hemostatic agents compared to physiologic hemostasis after endoscopic sinus surgery. [ Time Frame: 6 weeks post-operative ]

Participants will be monitored for 6 weeks. Means and standard deviations will be obtained for data collected from patient surveys rating subjective symptoms such as nasal obstruction, bleeding, pain, and nasal discharge on a scale ranging from 1-10 and investigator surveys evaluating the qualities of the patient's recovery (synechiae formation, granulation, edema, infection, and time spent debriding the sinuses) in response to intervention and compare this with the degree of epistaxis observed without therapy.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: St. Louis University

Dates:
Date Received: February 20, 2017
Date Started: May 13, 2014
Date Completion: March 31, 2018
Last Updated: February 24, 2017
Last Verified: February 2017