Status:
COMPLETED
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
Lead Sponsor:
Baxter Healthcare Corporation
Conditions:
Facial Rhytidectomy (Face-lift)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 post...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00708071
Start Date
June 1 2008
End Date
September 1 2008
Last Update
October 23 2012
Active Locations (6)
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1
Beverly Hills, California, United States
2
Los Angeles, California, United States
3
Atlanta, Georgia, United States
4
Evans, Georgia, United States