CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
ARTISS human fibrin sealantbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01684020
NCT01684020Phase 2Completed

A Prospective, Double-Blinded, Randomized Study Evaluating the Efficacy and Safety of ARTISS Human Fibrin Sealant as Used in External Rhinoplasty

DeNova Research·interventional·Posted Sep 12, 2012·Updated Nov 2, 2020

In Brief

A Phase 2 clinical trial evaluating ARTISS human fibrin sealant for Subjects Requesting and Requiring an Open Rhinoplasty. Completed, enrolled 10 participants across 1 site.

Detailed Summary

Rhinoplasty (nasal reconstruction i.e. "a nose job") is a surgical procedure performed on the nose to correct a medical problem or change the appearance of the nose. During the healing process, swelling and/or bruising is likely to occur. A drug called ARTISS Fibrin Sealant may or may not lessen these effects. This study is looking to see the effects of ARTISS on adhering tissue and improving wound healing in an external rhinoplasty. The purpose of this study is to evaluate the safety and effectiveness of rhinoplasty using ARTISS compared to rhinoplasty without using ARTISS in patients undergoing rhinoplasty performed through an external approach.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 12, 2012
Enrollment StartNov 28, 2012
Primary CompletionApr 26, 2016
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 13.8 years ago

Interventions

ARTISS human fibrin sealantbiological