Expired Study
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Hewlett, New York


Purpose:

The primary objective of this study is to evaluate the efficacy and safety of fibrin sealant with 4 IU/mL thrombin, vapor heated, solvent detergent treated (FS VH S/D 4) when used to reduce early postoperative bruising in participants undergoing a rhytidectomy (face-lift).


Criteria:

Inclusion Criteria: - Subjects planned for facial rhytidectomy - Subjects who read, understand and sign the written informed consent - Healthy female or male subjects as determined by the investigator using standard pre-operative assessments to include laboratory tests and ECG - Subjects 18-75 years old, inclusively - Subjects who are able and willing to comply with the protocol requirements - Female subjects of childbearing potential with a negative urine or serum pregnancy test within 72 hours of surgery Exclusion Criteria: - Pregnant or lactating women - Subjects who have undergone previous face-lift surgery - Subjects undergoing abbreviated face-lift procedures such as deep plane procedures, minimal undermining procedures, thread lifts, and minimal access cranial suspension - Subjects indicated for concurrent facial surgeries during the operation (e.g. forehead plasty, blepharoplasty, rhinoplasty, buccal fat removal, any filler injections including fat injections, lip augmentation, skin resurfacing procedures etc.) - Subjects indicated for additional procedures during the same operation (e.g., liposuction, mastoplasty etc.) - Subjects who had prior silicone injections to their face (Botox and/or Restylane are allowed) - Subjects considered by the investigator to be smokers - Subjects with ecchymosis and/or edema on the face on day 0, prior to surgery - Subjects with known (documented) bleeding or coagulation disorders - Subjects currently being treated with anti-coagulants - Subjects treated with Aspirin in the last 7 days or use of other Non-steroidal anti-inflammatory drug (NSAIDs) within the last 7 days prior to surgery - Subjects with vascular disorders, cardiovascular disease, and/or uncontrolled hypertension - Subjects with diabetes mellitus - Subjects with a history of Bell´s palsy - Subjects with connective tissue disorders - Subjects with documented history of pathologically or pharmacologically induced immune deficiency - Subjects receiving systemic corticosteroid treatment for a chronic condition within 2 to 30 days prior to the surgery - Subjects with a known sensitivity to fibrin sealants - Subjects with a known psychiatric disorder (e.g., depression, obsessive compulsive disorder, anxiety, eating disorders, etc) - Subjects who have participated in another clinical study within 30 days prior to this study


NCT ID:

NCT00708071


Primary Contact:

Study Director
Steve Z Abrams, MD
Baxter Healthcare Corporation


Backup Contact:

N/A


Location Contact:

Hewlett, New York
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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