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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty

NCTNCT01982760 (opens ClinicalTrials.gov in a new tab)Other id07-10-21
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 2
Enrollment
14 participants (actual)
Sponsor
University Hospitals Cleveland Medical Center · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Dec 2013
Primary completion
25 Jun 2015
Completion
25 Jun 2015
First posted
13 Nov 2013 (estimated)
Last update posted
16 Aug 2023
Conditions
Postoperative Ecchymosis

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016
  1. Ph 2

    DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty

    NCT01982760

    Dec 2013 to 25 Jun 2015

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • DDAVPDrug

Arms2

  • Experimental

    DDAVP

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

  • No intervention

    No DDAVP

    Patients Will not receive DDAVP prior to Rhinoplasty

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Reduction in Ecchymosis and Swelling

    Time frame · surgery to 8 days post-operatively

    Registry description

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

Secondary outcomes(1)

  1. Patient Behavior Factors

    Time frame · Surgery to 3 weeks post-operatively

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· surgery to 8 days post-operatively

Reduction in Ecchymosis and Swelling

GroupValue
DDAVPnot posted
No DDAVPnot posted
Secondary and other outcome results(1)
Secondary outcome· Surgery to 3 weeks post-operatively

Patient Behavior Factors

GroupValue
DDAVPnot posted
No DDAVPnot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
DDAVPArm receiving DDAVP prior to the operation. Drug is administered intravenously at .3mcg per kg, over 30 minutes prior to the operation. DDAVP: Patients Receiving DDAVP prior to operation–0 / 00 / 0
No DDAVPPatients Will not receive DDAVP prior to Rhinoplasty–0 / 00 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Undergoing Rhinoplasty where nasal bone osteotomy is necessary Exclusion Criteria: * Heart Disease * Renal Disease with decreased GFR * Liver Disease

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