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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00708071
First received: June 30, 2008
Last updated: October 19, 2012
Last verified: October 2012
  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).


Condition Intervention Phase
Facial Rhytidectomy (Face-lift)
Biological: Fibrin Sealant with 4 IU/ml Thrombin, Vapor-Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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 Rhytidectomy

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Visual Comparison of Ecchymosis at Postoperative Day 3 [ Time Frame: Through Postoperative Day 3 ] [ Designated as safety issue: No ]
    Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.

  • Incidence of Adverse Events (AEs) Related to Study Product (FS VH S/D 4) Throughout the Study Period [ Time Frame: Through Postoperative Day 14 (± 1) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Visual Comparison of Ecchymosis at Day 1 [ Time Frame: Through Postoperative Day 1 ] [ Designated as safety issue: No ]
    Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.

  • Visual Comparison of Ecchymosis at Day 5 [ Time Frame: Through Postoperative Day 5 ] [ Designated as safety issue: No ]
    Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.

  • Visual Comparison of Ecchymosis at Day 7 [ Time Frame: Through Postoperative Day 7 ] [ Designated as safety issue: No ]
    Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.

  • Visual Comparison of Ecchymosis at Day 10 [ Time Frame: Through Postoperative Day 10 ] [ Designated as safety issue: No ]
    Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.

  • Visual Comparison of Ecchymosis at Day 14 [ Time Frame: Through Postoperative Day 14 ] [ Designated as safety issue: No ]
    Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.

  • Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 1 [ Time Frame: Through Postoperative Day 1 ] [ Designated as safety issue: No ]

    Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)

    The planned and approved Statistical Analysis Plan (SAP) specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.


  • Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 3 [ Time Frame: Through Postoperative Day 3 ] [ Designated as safety issue: No ]

    Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)

    The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.


  • Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 5 [ Time Frame: Through Postoperative Day 5 ] [ Designated as safety issue: No ]

    Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)

    The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.


  • Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 7 [ Time Frame: Through Postoperative Day 7 ] [ Designated as safety issue: No ]

    Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)

    The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.


  • Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 10 [ Time Frame: Through Postoperative Day 10 ] [ Designated as safety issue: No ]

    Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)

    The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.


  • Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 14 [ Time Frame: Through Postoperative Day 14 ] [ Designated as safety issue: No ]

    Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)

    The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.


  • Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by a Blinded On-site Evaluator-Day 3 [ Time Frame: Postoperative Day 3 ] [ Designated as safety issue: No ]

    Difference between each side of the face are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)

    The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.


  • Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 1 [ Time Frame: Through Postoperative Day 1 ] [ Designated as safety issue: No ]

    Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4.

    Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil, Grade 2= Minor, Grade 3= Moderate, Grade 4= Marked/unusual amount.

    The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.


  • Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 3 [ Time Frame: Through Postoperative Day 3 ] [ Designated as safety issue: No ]

    Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.

    The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.


  • Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 5 [ Time Frame: Through Postoperative Day 5 ] [ Designated as safety issue: No ]

    Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.

    The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.


  • Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 7 [ Time Frame: Through Postoperative Day 7 ] [ Designated as safety issue: No ]

    Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.

    The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.


  • Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 10 [ Time Frame: Through Postoperative Day 10 ] [ Designated as safety issue: No ]

    Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.

    The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.


  • Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 14 [ Time Frame: Through Postoperative Day 14 ] [ Designated as safety issue: No ]

    Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.

    The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.


  • Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 1 [ Time Frame: Through Postoperative Day 1 ] [ Designated as safety issue: No ]

    Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)

    The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.


  • Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 3 [ Time Frame: Through Postoperative Day 3 ] [ Designated as safety issue: No ]

    Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)

    The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.


  • Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 5 [ Time Frame: Through Postoperative Day 5 ] [ Designated as safety issue: No ]

    Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)

    The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.


  • Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 7 [ Time Frame: Through Postoperative Day 7 ] [ Designated as safety issue: No ]

    Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)

    The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.


  • Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 10 [ Time Frame: Through Postoperative Day 10 ] [ Designated as safety issue: No ]

    Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)

    The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.


  • Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 14 [ Time Frame: Through Postoperative Day 14 ] [ Designated as safety issue: No ]

    Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)

    The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.


  • Resolution of Ecchymosis as Assessed by Investigators [ Time Frame: Postoperative Days 1, 3, 5, 7, 10, and 14 ] [ Designated as safety issue: No ]
    Resolution of ecchymosis (grade 0 on the Modified Marchac Scale for ecchymosis (Grade 0 = No bruising at all))

  • Resolution of Edema as Assessed by Investigators. [ Time Frame: Postoperative Days 1, 3, 5, 7, 10, and 14 ] [ Designated as safety issue: No ]
    Resolution of edema (grade 1 on the Marchac Scale for Edema (Grade 1 = Nil)

  • Total Volume of Drainage on Each Side of the Face [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: No ]
  • Participants With Hematoma/Seroma [ Time Frame: Days 0, 1, 3, 5, 7,10, and 14 ] [ Designated as safety issue: No ]
    Investigators assessed each side of the face for the presence of hematoma/seroma

  • Participants With Hematoma/Seroma During the Study [ Time Frame: Through Postoperative Day 14 (± 1) ] [ Designated as safety issue: No ]
    Investigators assessed each side of the face for the presence of hematoma/seroma

  • Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14 [ Time Frame: Postoperative Days 3, 7, 10, and 14 ] [ Designated as safety issue: No ]
    Two-point discrimination test performed by investigators to assess nerve regeneration. Testing performed on each side of the face (SoC and FS VH S/D 4). Differences are calculated as: Postoperative Day - Day 0, reported as minimal distance at which participants were able to discern feeling at two distinct points

  • Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4) [ Time Frame: Days 1, 3, 5, 7,10, and 14 ] [ Designated as safety issue: No ]

    Differences are calculated as (Grade for SoC) - (Grade for FS VH S/D 4). Participants used a 10-point visual analogue scale to complete a pain assessment for each side of their face during each postoperative study visit (Days 1, 3, 5, 7, 10, and 14). The higher the number, the greater the pain experienced, i.e. 10 = worst, 1 = least.

    The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.


  • Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4) [ Time Frame: Days 1, 3, 5, 7,10, and 14 ] [ Designated as safety issue: No ]

    Differences are calculated as (Grade for SoC) - (Grade for FS VH S/D 4). Participants used a 10-point visual analogue scale to complete a numbness assessment for each side of their face during each postoperative study visit (Days 1, 3, 5, 7, 10, and 14). The higher the number, the greater the numbness experienced, i.e. 10 = worst, 1 = least.

    The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.


  • Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) [ Time Frame: Postoperative Days 1, 3, 5, 7, 10, and 14 ] [ Designated as safety issue: No ]
    Participants compared the levels of bruising on each side of their face and determine if they had a preference for the look of 1 side over another.


Enrollment: 45
Study Start Date: June 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
Biological: Fibrin Sealant with 4 IU/ml Thrombin, Vapor-Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4)
Each subject received fibrin sealant with 4 IU/mL thrombin, vapor heated, solvent detergent treated containing synthetic aprotinin (FS VH S/D 4 ) to one side of the face. The dosing volume to be applied is 0.02 mL/cm2 to 0.04 mL/cm2. The study product will be applied to the subcutaneous plane in both the neck and the face area. The product will be applied using the spray device provided by the sponsor. (The other side of the face will be treated using standard of care.)
Other Names:
  • Fibrin Sealant
  • TISSEEL

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708071

Locations
United States, California
Beverly Hills, California, United States
Los Angeles, California, United States
United States, Georgia
Atlanta, Georgia, United States
Evans, Georgia, United States
United States, New York
Hewlett, New York, United States
United States, Tennessee
Chattanooga, Tennessee, United States
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Steve Z Abrams, MD Baxter Healthcare Corporation
  More Information

No publications provided by Baxter Healthcare Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00708071     History of Changes
Other Study ID Numbers: 550703
Study First Received: June 30, 2008
Results First Received: October 6, 2011
Last Updated: October 19, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Thrombin
Fibrin Tissue Adhesive
Aprotinin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014