Status:
COMPLETED
Efficacy and Safety of FS VH S/D 4 S-apr for Flap Adherence in Rhytidectomy
Lead Sponsor:
Baxter Healthcare Corporation
Conditions:
Face-lift
Facial Rhytidectomy
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to compare the safety and efficacy of FS VH S/D 4 s-apr versus standard of care in adhering tissue and improving wound healing in subjects undergoing facelift.
Eligibility Criteria
Inclusion
- Male or female subject is 18 to 75 years of age at the time of screening
- Subject is planned for facial rhytidectomy
- Subject has read, understood and signed the written informed consent
- Subject is healthy, as determined by the investigator using standard pre-operative assessments to include laboratory tests and electrocardiograms
- Subject is of childbearing potential, presents with a negative serum pregnancy test, and agrees to employ adequate birth control measures for the duration of the study
- Subject is willing and able to comply with the requirements of the protocol
Exclusion
- Subject is indicated for an abbreviated or modified face-lift procedure such as deep plane procedures, minimal undermining procedures, thread lifts, and minimal access cranial suspension
- Subject is indicated for concurrent facial surgeries during the operation (eg forehead plasty,blepharoplasty, rhinoplasty, buccal fat removal, any filler injections including fat injections, lip augmentation, skin resurfacing procedures etc.)
- Subject is indicated for additional procedures to the body during the same operation (eg liposuction, mastoplasty etc.)
- Subject has undergone a prior rhytidectomy surgery
- Subject is an active smoker, as assessed by the investigator
- Subject has a known (documented) bleeding or coagulation disorder
- Subject is being treated with anti-coagulants or with Aspirin (that was not discontinued 7 days prior to surgery)
- Subject has a vascular disorder, cardiovascular disease, and/or uncontrolled hypertension
- Subject has diabetes mellitus with glycosylated hemoglobin (HbA1c) \> 7
- Subject is receiving active treatment for a malignancy
- Subject has a connective tissue disorder
- Subject has an active or chronic skin disorder
- Subject has history of Bell's palsy
- Subject has a documented history of pathologically or pharmacologically induced immune deficiency
- Subject has received chronic treatment with immunosuppressive drugs, systemic corticosteroids, or other chronic treatments within 30 days prior to the surgery
- Subject has a known sensitivity to components of FS VH S/D 4 s-apr
- Subject has a known psychiatric disorder (eg, obsessive compulsive disorder, anxiety, eating disorders, etc.)
- Subject has documented healing complications following previous surgeries (eg, hypertrophic scarring)
- Subject is pregnant or lactating at the time of enrollment
- Subject has participated in another clinical study involving an investigational product/device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational product/device during the course of this study
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00999141
Start Date
September 1 2009
End Date
February 1 2010
Last Update
October 8 2012
Active Locations (6)
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1
Beverly Hills, California, United States
2
Atlanta, Georgia, United States
3
Evans, Georgia, United States
4
Hewlett, New York, United States