Postoperative Ecchymosis
Conditions
Keywords
Rhinoplasty, Ecchymosis, Edema
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.
Interventions
DRUGDDAVP
Patients Receiving DDAVP prior to operation
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Undergoing Rhinoplasty where nasal bone osteotomy is necessary
Exclusion criteria
* Heart Disease * Renal Disease with decreased GFR * Liver Disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Ecchymosis and Swelling | surgery to 8 days post-operatively | Photographs taken preoperatively at 1 day and 8 days post-operatively will be analyzed for bruising |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Behavior Factors | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DDAVP Arm 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 | 14 |
| No DDAVP Patients Will not receive DDAVP prior to Rhinoplasty | 0 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | DDAVP | No DDAVP | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 0 Participants | 14 Participants |
| Sex: Female, Male Female | 9 Participants | 0 Participants | 9 Participants |
| Sex: Female, Male Male | 5 Participants | 0 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Reduction in Ecchymosis and Swelling
Photographs taken preoperatively at 1 day and 8 days post-operatively will be analyzed for bruising
Time frame: surgery to 8 days post-operatively
Population: No data collected
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
Time frame: Surgery to 3 weeks post-operatively
Population: No data collected