DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty

NCT01982760 | Terminated Phase 2 Results DMC

• 1 other identifier: 07-10-21
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Ecchymosis

Keywords

Rhinoplasty; Ecchymosis; Edema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Behavior Factors

  Surgery to 3 weeks post-operatively

Study Arms (2)

DDAVP

EXPERIMENTAL

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

Drug: DDAVP

No DDAVP

NO INTERVENTION

Patients Will not receive DDAVP prior to Rhinoplasty

Interventions

DDAVP DRUG

Patients Receiving DDAVP prior to operation

Also known as: Desmopressin

DDAVP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing Rhinoplasty where nasal bone osteotomy is necessary

You may not qualify if:

• Heart Disease
• Renal Disease with decreased GFR
• Liver Disease

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

Lyndhurst Surgery Center

Lyndhurst, Ohio, 44124, United States

Location

MeSH Terms

Conditions

Ecchymosis; Edema

Interventions

Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Dr. Bahman Guyuron
• Organization: Case School of Medicine

bguyuron@guyuron.com

440-461-7999

Study Officials

• Bahman Guyuron, MD

  University Hospitals

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 13, 2013
• Study Start: December 1, 2013
• Primary Completion: June 25, 2015
• Study Completion: June 25, 2015
• Last Updated: August 16, 2023
• Results First Posted: August 16, 2023

Record last verified: 2023-07

Locations

US (1)