Clinical trial

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

Name
07-10-21
Description
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.
Trial arms
Trial start
2013-12-01
Estimated PCD
2015-06-25
Trial end
2015-06-25
Status
Terminated
Phase
Early phase I
Treatment
DDAVP
Patients Receiving DDAVP prior to operation
Arms:
DDAVP
Other names:
Desmopressin
Size
14
Primary endpoint
Reduction in Ecchymosis and Swelling
surgery to 8 days post-operatively
Eligibility criteria
Inclusion Criteria: * Undergoing Rhinoplasty where nasal bone osteotomy is necessary Exclusion Criteria: * Heart Disease * Renal Disease with decreased GFR * Liver Disease
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 14, 'type': 'ACTUAL'}}
Updated at
2023-08-16

1 organization

1 product

1 indication

Product
DDAVP