DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty

July 26, 2023 updated by: University Hospitals Cleveland Medical Center

A Prospective Randomized Trial for the Use of DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty.

This is study looking at the use of a medication, Desmopressin acetate (DDAVP), to reduce bleeding, swelling, and bruising in patients undergoing cosmetic nose surgery. DDAVP is a drug used in patients with bleeding disorders. It works by activating molecules in the blood stream called platelets that promote clotting. In the study, participants who are have cosmetic nose surgery (rhinoplasty) will be randomly assigned to receive or not receive medication. Photographs taken before and shortly after surgery will be evaluated for the amount of bruising and swelling. Patients with heart, lung, kidney, or liver problems are not eligible to participate.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Lyndhurst, Ohio, United States, 44124
        • Lyndhurst Surgery Center
        • Contact:
        • Principal Investigator:
          • Bahman Guyuron, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Undergoing Rhinoplasty where nasal bone osteotomy is necessary

Exclusion Criteria:

  • Heart Disease
  • Renal Disease with decreased GFR
  • Liver Disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DDAVP
Arm receiving DDAVP prior to the operation. Drug is administered intravenously at .3mcg per kg, over 30 minutes prior to the operation.
Drug: DDAVP
Patients Receiving DDAVP prior to operation
Other Names:
  • Desmopressin
No Intervention: No DDAVP
Patients Will not receive DDAVP prior to Rhinoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Ecchymosis and Swelling
Time Frame: surgery to 8 days post-operatively
Photographs taken preoperatively at 1 day and 8 days post-operatively will be analyzed for bruising
surgery to 8 days post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Behavior Factors
Time Frame: Surgery to 3 weeks post-operatively
Looking at the time it takes for patients to feel comfortable wearing makeup, going out in public, and returning to work
Surgery to 3 weeks post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Investigators

  • Principal Investigator: Bahman Guyuron, MD, University Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Actual)

June 25, 2015

Study Completion (Actual)

June 25, 2015

Study Registration Dates

First Submitted

November 5, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (Estimated)

November 13, 2013

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-10-21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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