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

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

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).

Study Overview

• Status: Completed
• Conditions: Facial Rhytidectomy (Face-lift)
• Intervention / Treatment: Biological: Fibrin Sealant with 4 IU/ml Thrombin, Vapor-Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4)

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States
    • Los Angeles, California, United States
  • Georgia
    • Atlanta, Georgia, United States
    • Evans, Georgia, United States
  • New York
    • Hewlett, New York, United States
  • Tennessee
    • Chattanooga, Tennessee, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Comparison of Ecchymosis at Postoperative Day 3	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.	Through Postoperative Day 3
Incidence of Adverse Events (AEs) Related to Study Product (FS VH S/D 4) Throughout the Study Period		Through Postoperative Day 14 (± 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Comparison of Ecchymosis at Day 1	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.	Through Postoperative Day 1
Visual Comparison of Ecchymosis at Day 5	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.	Through Postoperative Day 5
Visual Comparison of Ecchymosis at Day 7	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.	Through Postoperative Day 7
Visual Comparison of Ecchymosis at Day 10	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.	Through Postoperative Day 10
Visual Comparison of Ecchymosis at Day 14	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.	Through Postoperative Day 14
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	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.	Through Postoperative Day 1
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	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.	Through Postoperative Day 3
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	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.	Through Postoperative Day 5
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	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.	Through Postoperative Day 7
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	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.	Through Postoperative Day 10
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	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.	Through Postoperative Day 14
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	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.	Postoperative Day 3
Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 1	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.	Through Postoperative Day 1
Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 3	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.	Through Postoperative Day 3
Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 5	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.	Through Postoperative Day 5
Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 7	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.	Through Postoperative Day 7
Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 10	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.	Through Postoperative Day 10
Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 14	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.	Through Postoperative Day 14
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 1	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.	Through Postoperative Day 1
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 3	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.	Through Postoperative Day 3
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 5	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.	Through Postoperative Day 5
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 7	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.	Through Postoperative Day 7
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 10	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.	Through Postoperative Day 10
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 14	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.	Through Postoperative Day 14
Resolution of Ecchymosis as Assessed by Investigators	Resolution of ecchymosis (grade 0 on the Modified Marchac Scale for ecchymosis (Grade 0 = No bruising at all))	Postoperative Days 1, 3, 5, 7, 10, and 14
Resolution of Edema as Assessed by Investigators.	Resolution of edema (grade 1 on the Marchac Scale for Edema (Grade 1 = Nil)	Postoperative Days 1, 3, 5, 7, 10, and 14
Total Volume of Drainage on Each Side of the Face		24 hours postoperative
Participants With Hematoma/Seroma	Investigators assessed each side of the face for the presence of hematoma/seroma	Days 0, 1, 3, 5, 7,10, and 14
Participants With Hematoma/Seroma During the Study	Investigators assessed each side of the face for the presence of hematoma/seroma	Through Postoperative Day 14 (± 1)
Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14	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	Postoperative Days 3, 7, 10, and 14
Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4)	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.	Days 1, 3, 5, 7,10, and 14
Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4)	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.	Days 1, 3, 5, 7,10, and 14
Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4)	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.	Postoperative Days 1, 3, 5, 7, 10, and 14

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Investigators: Study Director: Steve Z Abrams, MD, Baxter Healthcare Corporation

Publications and helpful links

General Publications

• Hester TR Jr, Gerut ZE, Shire JR, Nguyen DB, Chen AH, Diamond J, Desmond JC, Silvati-Fidell L, Abrams SZ. Exploratory, randomized, controlled, phase 2 study to evaluate the safety and efficacy of adjuvant fibrin sealant VH S/D 4 S-Apr (ARTISS) in patients undergoing rhytidectomy. Aesthet Surg J. 2013 Mar;33(3):323-33. doi: 10.1177/1090820X13477860.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: June 30, 2008
• First Submitted That Met QC Criteria: June 30, 2008
• First Posted (Estimate): July 2, 2008

Study Record Updates

• Last Update Posted (Estimate): October 23, 2012
• Last Update Submitted That Met QC Criteria: October 19, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Serine Proteinase Inhibitors; Hemostatics; Coagulants; Trypsin Inhibitors; Fibrin Tissue Adhesive; Thrombin; Aprotinin
• Other Study ID Numbers: 550703

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No