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DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty

Primary Purpose

Postoperative Ecchymosis

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

DDAVP

About this trial

This is an interventional treatment trial for Postoperative Ecchymosis focused on measuring Rhinoplasty, Ecchymosis, Edema

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Undergoing Rhinoplasty where nasal bone osteotomy is necessary

Exclusion Criteria:

Heart Disease
Renal Disease with decreased GFR
Liver Disease

Sites / Locations

Lyndhurst Surgery Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

DDAVP

No DDAVP

Arm Description

Arm receiving DDAVP prior to the operation. Drug is administered intravenously at .3mcg per kg, over 30 minutes prior to the operation.

Patients Will not receive DDAVP prior to Rhinoplasty

Outcomes

Primary Outcome Measures

Reduction in Ecchymosis and Swelling

Photographs taken preoperatively at 1 day and 8 days post-operatively will be analyzed for bruising

Secondary Outcome Measures

Patient Behavior Factors

Looking at the time it takes for patients to feel comfortable wearing makeup, going out in public, and returning to work

Full Information

NCT ID

NCT01982760

First Posted

November 5, 2013

Last Updated

July 26, 2023

Sponsor

University Hospitals Cleveland Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01982760

Brief Title

DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Terminated

Study Start Date

December 2013 (Actual)

Primary Completion Date

June 25, 2015 (Actual)

Study Completion Date

June 25, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospitals Cleveland Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Ecchymosis

Keywords

Rhinoplasty, Ecchymosis, Edema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DDAVP

Arm Type

Experimental

Arm Description

Arm receiving DDAVP prior to the operation. Drug is administered intravenously at .3mcg per kg, over 30 minutes prior to the operation.

Arm Title

No DDAVP

Arm Type

No Intervention

Arm Description

Patients Will not receive DDAVP prior to Rhinoplasty

Intervention Type

Drug

Intervention Name(s)

DDAVP

Other Intervention Name(s)

Desmopressin

Intervention Description

Patients Receiving DDAVP prior to operation

Primary Outcome Measure Information:

Title

Reduction in Ecchymosis and Swelling

Description

Photographs taken preoperatively at 1 day and 8 days post-operatively will be analyzed for bruising

Time Frame

surgery to 8 days post-operatively

Secondary Outcome Measure Information:

Title

Patient Behavior Factors

Description

Looking at the time it takes for patients to feel comfortable wearing makeup, going out in public, and returning to work

Time Frame

Surgery to 3 weeks post-operatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Undergoing Rhinoplasty where nasal bone osteotomy is necessary Exclusion Criteria: Heart Disease Renal Disease with decreased GFR Liver Disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bahman Guyuron, MD

Organizational Affiliation

University Hospitals

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lyndhurst Surgery Center

City

Lyndhurst

State/Province

Ohio

ZIP/Postal Code

44124

Country

United States

12. IPD Sharing Statement

Learn more about this trial

DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty

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