DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty

Postoperative Ecchymosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01982760
• Other study ID #: 07-10-21
• Status: Terminated
• Phase: Phase 2
• Start date: December 2013
• Est. completion date: June 25, 2015

Study information

• Verified date: July 2023
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: June 25, 2015
• Est. primary completion date: June 25, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Undergoing Rhinoplasty where nasal bone osteotomy is necessary

Exclusion Criteria:

• Heart Disease

• Renal Disease with decreased GFR

• Liver Disease

Related Conditions & MeSH terms

• Ecchymosis
• Postoperative Ecchymosis

Intervention

Drug:
• DDAVP
Patients Receiving DDAVP prior to operation

Locations

Country	Name	City	State
United States	Lyndhurst Surgery Center	Lyndhurst	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Ecchymosis and Swelling	Photographs taken preoperatively at 1 day and 8 days post-operatively will be analyzed for bruising	surgery to 8 days post-operatively
Secondary	Patient Behavior Factors	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