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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DDAVP | Experimental | Arm receiving DDAVP prior to the operation. Drug is administered intravenously at .3mcg per kg, over 30 minutes prior to the operation. |
|
| No DDAVP | No Intervention | Patients Will not receive DDAVP prior to Rhinoplasty |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DDAVP | Drug | Patients Receiving DDAVP prior to operation |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bahman Guyuron, MD | University Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyndhurst Surgery Center | Lyndhurst | Ohio | 44124 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | No DDAVP | Patients Will not receive DDAVP prior to Rhinoplasty |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
No patients were enrolled in the control arm as the study was terminated.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | No DDAVP |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reduction in Ecchymosis and Swelling | Photographs taken preoperatively at 1 day and 8 days post-operatively will be analyzed for bruising | No data collected | Posted | surgery to 8 days post-operatively |
|
AE data not collected
No AE data collected since study was terminated
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bahman Guyuron | Case School of Medicine | 440-461-7999 | bguyuron@guyuron.com |
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| ID | Term |
|---|---|
| D004438 | Ecchymosis |
| D004487 | Edema |
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006470 | Hemorrhage |
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| ID | Term |
|---|---|
| D003894 | Deamino Arginine Vasopressin |
| ID | Term |
|---|---|
| D001127 | Arginine Vasopressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
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Patients Will not receive DDAVP prior to Rhinoplasty
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| 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 | No data collected | Posted | Surgery to 3 weeks post-operatively |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | No DDAVP | Patients Will not receive DDAVP prior to Rhinoplasty | 0 | 0 | 0 | 0 |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D036361 |
| Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |