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Efficacy and Safety Study of FS VH S/D 4 in Face-Lift Procedures

This study is currently recruiting participants.
Study NCT00708071.   Last updated on July 7, 2008.   Information provided by Baxter Healthcare Corporation

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Descriptive Information Fields
Brief Title † Efficacy and Safety Study of FS VH S/D 4 in Face-Lift Procedures
Official Title † An Exploratory Phase 2 Clinical Study to Evaluate Efficacy and Safety of the Adjuvant Use of Fibrin Sealant With 4 IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4) in Subjects Undergoing Facial Rhytidectomy
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 postoperative bruising in subjects undergoing a face-lift.
Detailed Description
Study Phase Phase II
Study Type † Interventional
Study Design † Treatment, Randomized, Single Blind (Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure † Visual comparison of ecchymosis at postoperative Day 3 between the FS VH S/D 4 -treated side of the face and the side treated using standard of care as assessed by 3 separate blinded reviewers using standard digital photographs [ Time Frame: Until the final follow-up visit at postoperative Day 14 (± 1) ] [ Designated as safety issue: No ]
Secondary Outcome Measure †
Condition † Face-Lift
Facial Rhytidectomy
Intervention † Drug: FS VH S/D 4 (Fibrin Sealant with 4 IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated)
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status † Recruiting
Enrollment † 40
Start Date † June 2008
Completion Date
Eligibility 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 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
Gender Both
Ages 18 Years to 75 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries † United States
Administrative Information Fields
NCT ID † NCT00708071
Organization ID 550703
Secondary IDs ††
Study Sponsor † Baxter Healthcare Corporation
Collaborators ††
Investigators †
Study Director:     Steve Z Abrams, MD     Baxter Healthcare Corporation    
Information Provided By Baxter Healthcare Corporation
Verification Date July 2008
First Received Date † June 30, 2008
Last Updated Date July 7, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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