Clareo Health | Efficacy and Safety Study of Fibrin Sealant With 4 IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated (FS VH S/D 4) in Face-Lift Procedures
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Baxter Healthcare Corporation
Age
18–75
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
