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A Study Evaluating the Efficacy and Safety of ARTISS Human Fibrin Sealant as Used in External Rhinoplasty

NCT01684020 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-11-02

Study results available
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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.

Conditions

  • Subjects Requesting and Requiring an Open Rhinoplasty

Interventions

BIOLOGICAL

ARTISS human fibrin sealant

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • DeNova Research

    lead OTHER

Principal Investigators

  • Steven H Dayan, MD · DeNova Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-28
Primary Completion
2016-04-26
Completion
2016-04-26

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01684020 on ClinicalTrials.gov