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DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01982760
Recruitment Status : Unknown
Verified November 2013 by Bahman Guyuron, University Hospitals Cleveland Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 13, 2013
Last Update Posted : November 15, 2013
Sponsor:
Information provided by (Responsible Party):
Bahman Guyuron, University Hospitals Cleveland Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postoperative Ecchymosis Drug: DDAVP Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial for the Use of DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty.
Study Start Date : December 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


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 Name: Desmopressin

No Intervention: No DDAVP
Patients Will not receive DDAVP prior to Rhinoplasty



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing Rhinoplasty where nasal bone osteotomy is necessary

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01982760


Locations
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United States, Ohio
Lyndhurst Surgery Center Not yet recruiting
Lyndhurst, Ohio, United States, 44124
Contact: Bahman Guyuron, MD    440-461-7999    bahman.guyuron@uhhospitals.org   
Principal Investigator: Bahman Guyuron, MD         
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Investigators
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Principal Investigator: Bahman Guyuron, MD University Hospitals

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Responsible Party: Bahman Guyuron, MD, FAC, Chair of Department of Plastic Surgery, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT01982760    
Other Study ID Numbers: 07-10-21
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: November 15, 2013
Last Verified: November 2013
Keywords provided by Bahman Guyuron, University Hospitals Cleveland Medical Center:
Rhinoplasty
Ecchymosis
Edema
Additional relevant MeSH terms:
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Ecchymosis
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs