Trial Outcomes & Findings for 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 (NCT NCT00708071)

NCT ID: NCT00708071

Last Updated: 2012-10-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 45 participants
• Primary outcome timeframe: Through Postoperative Day 3
• Results posted on: 2012-10-23

Participant Flow

Patients were enrolled at 6 clinical sites in the United States, beginning June 2008 and completing in September 2008

56 participants were enrolled and screened. 2 were screen failures. 9 were withdrawn prior to randomization (1 due to untoward medical occurrence, 2 due to study site over enrollment, 2 requested withdrawal, 2 had scheduling conflicts, 1 had surgery delayed, 1 missed deadline for enrollment. Therefore, 45 of the 56 enrolled were randomized.

Participant milestones

Measure	Facelift Participants 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.
Overall Study STARTED	45
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Facelift Participants n=45 Participants 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.
Age Continuous	55.1 years STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants

PRIMARY outcome

Timeframe: Through Postoperative Day 3

Population: Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=28 Participants	Participants With Less Ecchymosis Treated With SoC n=28 Participants	Participants With Equal Ecchymosis On Both Sides n=28 Participants	Participants With No Ecchymosis on Either Side n=28 Participants	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Visual Comparison of Ecchymosis at Postoperative Day 3	5 participants	12 participants	11 participants	0 participants	—	—	—	—

PRIMARY outcome

Timeframe: Through Postoperative Day 14 (± 1)

Population: Safety Data Set

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=45 Participants	Participants With Less Ecchymosis Treated With SoC	Participants With Equal Ecchymosis On Both Sides	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Incidence of Adverse Events (AEs) Related to Study Product (FS VH S/D 4) Throughout the Study Period	0 Adverse Events	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through Postoperative Day 1

Population: Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=29 Participants	Participants With Less Ecchymosis Treated With SoC n=29 Participants	Participants With Equal Ecchymosis On Both Sides n=29 Participants	Participants With No Ecchymosis on Either Side n=29 Participants	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Visual Comparison of Ecchymosis at Day 1	2 participants	11 participants	16 participants	0 participants	—	—	—	—

SECONDARY outcome

Timeframe: Through Postoperative Day 5

Population: Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=27 Participants	Participants With Less Ecchymosis Treated With SoC n=27 Participants	Participants With Equal Ecchymosis On Both Sides n=27 Participants	Participants With No Ecchymosis on Either Side n=27 Participants	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Visual Comparison of Ecchymosis at Day 5	5 participants	8 participants	14 participants	0 participants	—	—	—	—

SECONDARY outcome

Timeframe: Through Postoperative Day 7

Population: Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=31 Participants	Participants With Less Ecchymosis Treated With SoC n=31 Participants	Participants With Equal Ecchymosis On Both Sides n=31 Participants	Participants With No Ecchymosis on Either Side n=31 Participants	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Visual Comparison of Ecchymosis at Day 7	9 participants	8 participants	14 participants	0 participants	—	—	—	—

SECONDARY outcome

Timeframe: Through Postoperative Day 10

Population: Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=28 Participants	Participants With Less Ecchymosis Treated With SoC n=28 Participants	Participants With Equal Ecchymosis On Both Sides n=28 Participants	Participants With No Ecchymosis on Either Side n=28 Participants	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Visual Comparison of Ecchymosis at Day 10	7 participants	7 participants	14 participants	0 participants	—	—	—	—

SECONDARY outcome

Timeframe: Through Postoperative Day 14

Population: Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=26 Participants	Participants With Less Ecchymosis Treated With SoC n=26 Participants	Participants With Equal Ecchymosis On Both Sides n=26 Participants	Participants With No Ecchymosis on Either Side n=26 Participants	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Visual Comparison of Ecchymosis at Day 14	5 participants	6 participants	14 participants	1 participants	—	—	—	—

SECONDARY outcome

Timeframe: Through Postoperative Day 1

Population: Per Protocol

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC	Participants With Equal Ecchymosis On Both Sides	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - 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	0.0 Scores on a scale Interval -0.2 to 0.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through Postoperative Day 3

Population: Per Protocol

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC	Participants With Equal Ecchymosis On Both Sides	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - 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 3	-0.2 Scores on a scale Interval -0.4 to 0.2	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through Postoperative Day 5

Population: Per Protocol

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC	Participants With Equal Ecchymosis On Both Sides	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - 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 5	0.0 Scores on a scale Interval 0.0 to 0.2	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through Postoperative Day 7

Population: Per Protocol

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC	Participants With Equal Ecchymosis On Both Sides	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - 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 7	0.0 Scores on a scale Interval -0.2 to 0.2	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through Postoperative Day 10

Population: Per Protocol

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC	Participants With Equal Ecchymosis On Both Sides	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - 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 10	0.0 Scores on a scale Interval -0.4 to 0.2	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through Postoperative Day 14

Population: Per Protocol

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC	Participants With Equal Ecchymosis On Both Sides	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - 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 14	0.0 Scores on a scale Interval -0.2 to 0.4	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Postoperative Day 3

Population: Per Protocol

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC	Participants With Equal Ecchymosis On Both Sides	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - 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	0.00 Scores on a scale Interval -3.0 to 1.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through Postoperative Day 1

Population: Per Protocol

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=32 Participants	Participants With Less Ecchymosis Treated With SoC	Participants With Equal Ecchymosis On Both Sides	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 1	0.00 Scores on a scale Interval 0.0 to 0.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through Postoperative Day 3

Population: Per Protocol

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC	Participants With Equal Ecchymosis On Both Sides	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 3	0.0 Scores on a scale Interval 0.0 to 0.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through Postoperative Day 5

Population: Per Protocol

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC	Participants With Equal Ecchymosis On Both Sides	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 5	0.0 Scores on a scale Interval 0.0 to 0.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through Postoperative Day 7

Population: Per Protocol

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC	Participants With Equal Ecchymosis On Both Sides	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 7	0.0 Scores on a scale Interval 0.0 to 0.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through Postoperative Day 10

Population: Per Protocol

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=32 Participants	Participants With Less Ecchymosis Treated With SoC	Participants With Equal Ecchymosis On Both Sides	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 10	0.0 Scores on a scale Interval 0.0 to 0.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through Postoperative Day 14

Population: Per Protocol

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC	Participants With Equal Ecchymosis On Both Sides	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 14	0.0 Scores on a scale Interval 0.0 to 0.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through Postoperative Day 1

Population: Per Protocol

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC	Participants With Equal Ecchymosis On Both Sides	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 1	0.0 Scores on a scale Interval 0.0 to 0.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through Postoperative Day 3

Population: Per Protocol

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC	Participants With Equal Ecchymosis On Both Sides	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 3	0.0 Scores on a scale Interval 0.0 to 0.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through Postoperative Day 5

Population: Per Protocol

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC	Participants With Equal Ecchymosis On Both Sides	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 5	0.0 Scores on a scale Interval 0.0 to 1.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through Postoperative Day 7

Population: Per Protocol

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC	Participants With Equal Ecchymosis On Both Sides	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 7	0.0 Scores on a scale Interval 0.0 to 0.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through Postoperative Day 10

Population: Per Protocol

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC	Participants With Equal Ecchymosis On Both Sides	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 10	0.0 Scores on a scale Interval 0.0 to 0.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through Postoperative Day 14

Population: Per Protocol

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC	Participants With Equal Ecchymosis On Both Sides	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 14	0.0 Scores on a scale Interval 0.0 to 0.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Postoperative Days 1, 3, 5, 7, 10, and 14

Population: Per Protocol

Resolution of ecchymosis (grade 0 on the Modified Marchac Scale for ecchymosis (Grade 0 = No bruising at all))

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC n=33 Participants	Participants With Equal Ecchymosis On Both Sides n=33 Participants	Participants With No Ecchymosis on Either Side n=33 Participants	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Resolution of Ecchymosis as Assessed by Investigators By Day 1	0 participants	0 participants	2 participants	31 participants	—	—	—	—
Resolution of Ecchymosis as Assessed by Investigators By Day 3	0 participants	0 participants	1 participants	32 participants	—	—	—	—
Resolution of Ecchymosis as Assessed by Investigators By Day 5	1 participants	0 participants	0 participants	32 participants	—	—	—	—
Resolution of Ecchymosis as Assessed by Investigators By Day 7	1 participants	0 participants	0 participants	32 participants	—	—	—	—
Resolution of Ecchymosis as Assessed by Investigators By Day 10	1 participants	0 participants	1 participants	31 participants	—	—	—	—
Resolution of Ecchymosis as Assessed by Investigators By Day 14	1 participants	3 participants	7 participants	22 participants	—	—	—	—

SECONDARY outcome

Timeframe: Postoperative Days 1, 3, 5, 7, 10, and 14

Population: Per Protocol

Resolution of edema (grade 1 on the Marchac Scale for Edema (Grade 1 = Nil)

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC n=33 Participants	Participants With Equal Ecchymosis On Both Sides n=33 Participants	Participants With No Ecchymosis on Either Side n=33 Participants	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Resolution of Edema as Assessed by Investigators. By Day 1 (n=32)	3 participants	0 participants	0 participants	29 participants	—	—	—	—
Resolution of Edema as Assessed by Investigators. By Day 3 (n=33)	0 participants	0 participants	0 participants	33 participants	—	—	—	—
Resolution of Edema as Assessed by Investigators. By Day 5 (n=33)	0 participants	0 participants	0 participants	33 participants	—	—	—	—
Resolution of Edema as Assessed by Investigators. By Day 7 (n=33)	1 participants	0 participants	1 participants	33 participants	—	—	—	—
Resolution of Edema as Assessed by Investigators. By Day 10 (n=32)	1 participants	0 participants	1 participants	30 participants	—	—	—	—
Resolution of Edema as Assessed by Investigators. By Day 14 (n=32)	4 participants	2 participants	6 participants	20 participants	—	—	—	—

SECONDARY outcome

Timeframe: 24 hours postoperative

Population: Per Protocol

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC n=33 Participants	Participants With Equal Ecchymosis On Both Sides	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Total Volume of Drainage on Each Side of the Face	16 mL Interval 0.0 to 100.0	5 mL Interval 0.0 to 50.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 0, 1, 3, 5, 7,10, and 14

Population: Per Protocol

Investigators assessed each side of the face for the presence of hematoma/seroma

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC n=33 Participants	Participants With Equal Ecchymosis On Both Sides	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Participants With Hematoma/Seroma Day 7	1 Participants	0 Participants	—	—	—	—	—	—
Participants With Hematoma/Seroma Day 10	2 Participants	0 Participants	—	—	—	—	—	—
Participants With Hematoma/Seroma Day 0	2 Participants	0 Participants	—	—	—	—	—	—
Participants With Hematoma/Seroma Day 1	1 Participants	0 Participants	—	—	—	—	—	—
Participants With Hematoma/Seroma Day 3	2 Participants	0 Participants	—	—	—	—	—	—
Participants With Hematoma/Seroma Day 5	1 Participants	0 Participants	—	—	—	—	—	—
Participants With Hematoma/Seroma Day 14	1 Participants	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through Postoperative Day 14 (± 1)

Population: Per protocol

Investigators assessed each side of the face for the presence of hematoma/seroma

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC n=33 Participants	Participants With Equal Ecchymosis On Both Sides n=33 Participants	Participants With No Ecchymosis on Either Side n=33 Participants	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Participants With Hematoma/Seroma During the Study	0 participants	6 participants	0 participants	27 participants	—	—	—	—

SECONDARY outcome

Timeframe: Postoperative Days 3, 7, 10, and 14

Population: Per protocol

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

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC n=33 Participants	Participants With Equal Ecchymosis On Both Sides n=33 Participants	Participants With No Ecchymosis on Either Side n=33 Participants	FS VH S/D 4 - Day 10 n=33 Participants	SoC - Day 10 n=33 Participants	FS VH S/D 4 - Day 14 n=33 Participants	SoC - Day 14 n=33 Participants
Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14	7 mm Interval -12.0 to 48.0	7 mm Interval -5.0 to 44.0	5 mm Interval -20.0 to 48.0	6 mm Interval -10.0 to 59.0	5 mm Interval -32.0 to 37.0	5 mm Interval -10.0 to 45.0	0 mm Interval -41.0 to 38.0	5 mm Interval -13.0 to 39.0

SECONDARY outcome

Timeframe: Days 1, 3, 5, 7,10, and 14

Population: Per Protocol

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC	Participants With Equal Ecchymosis On Both Sides	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4) Day 3	0 Scores on a scale Interval -4.0 to 4.0	—	—	—	—	—	—	—
Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4) Day 1	0 Scores on a scale Interval -4.0 to 3.0	—	—	—	—	—	—	—
Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4) Day 5	0 Scores on a scale Interval -5.0 to 3.0	—	—	—	—	—	—	—
Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4) Day 7	0 Scores on a scale Interval -4.0 to 2.0	—	—	—	—	—	—	—
Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4) Day 10	0 Scores on a scale Interval -1.0 to 2.0	—	—	—	—	—	—	—
Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4) Day 14	0 Scores on a scale Interval -1.0 to 3.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 1, 3, 5, 7,10, and 14

Population: Per Protocol

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC	Participants With Equal Ecchymosis On Both Sides	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4) Day 5	0 Scores on a scale Interval -2.0 to 4.0	—	—	—	—	—	—	—
Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4) Day 7	0 Scores on a scale Interval -3.0 to 3.0	—	—	—	—	—	—	—
Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4) Day 10	0 Scores on a scale Interval -2.0 to 2.0	—	—	—	—	—	—	—
Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4) Day 1	0 Scores on a scale Interval -4.0 to 4.0	—	—	—	—	—	—	—
Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4) Day 3	0 Scores on a scale Interval -7.0 to 4.0	—	—	—	—	—	—	—
Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4) Day 14	0 Scores on a scale Interval -3.0 to 2.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Postoperative Days 1, 3, 5, 7, 10, and 14

Population: Per Protocol

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.

Outcome measures

Measure	Participants With Less Ecchymosis Treated With FS VH S/D 4 n=33 Participants	Participants With Less Ecchymosis Treated With SoC n=33 Participants	Participants With Equal Ecchymosis On Both Sides n=33 Participants	Participants With No Ecchymosis on Either Side	FS VH S/D 4 - Day 10	SoC - Day 10	FS VH S/D 4 - Day 14	SoC - Day 14
Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) Day 1	5 participants	12 participants	16 participants	—	—	—	—	—
Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) Day 3	1 participants	20 participants	12 participants	—	—	—	—	—
Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) Day 5	2 participants	17 participants	14 participants	—	—	—	—	—
Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) Day 7	2 participants	17 participants	14 participants	—	—	—	—	—
Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) Day 10	5 participants	13 participants	15 participants	—	—	—	—	—
Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) Day 14	5 participants	12 participants	15 participants	—	—	—	—	—

Adverse Events

Localized to SoC Side of Face

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Localized to FS VH S/D 4 Side of Face

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Non-localized AEs

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Localized to SoC Side of Face n=45 participants at risk AE was localized to the side of the face which was treated with standard of care.	Localized to FS VH S/D 4 Side of Face n=45 participants at risk AE was localized to the side of the face which was treated with FS VH S/D 4.	Non-localized AEs n=45 participants at risk AE affected a site other than either side of the face (ie, non-localized AE)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	2.2% 1/45 • Number of events 1 • Approximately 16 weeks	0.00% 0/45 • Approximately 16 weeks	0.00% 0/45 • Approximately 16 weeks

Other adverse events

Measure	Localized to SoC Side of Face n=45 participants at risk AE was localized to the side of the face which was treated with standard of care.	Localized to FS VH S/D 4 Side of Face n=45 participants at risk AE was localized to the side of the face which was treated with FS VH S/D 4.	Non-localized AEs n=45 participants at risk AE affected a site other than either side of the face (ie, non-localized AE)
General disorders Oedema	6.7% 3/45 • Number of events 4 • Approximately 16 weeks	6.7% 3/45 • Number of events 3 • Approximately 16 weeks	0.00% 0/45 • Approximately 16 weeks
Vascular disorders Haematoma	15.6% 7/45 • Number of events 7 • Approximately 16 weeks	0.00% 0/45 • Approximately 16 weeks	0.00% 0/45 • Approximately 16 weeks

Additional Information

Edith Hantak, DVM, Dir, Global Therapeutic Area, BioSurgery

Baxter Innovations, GmbH

Email: edith_hantak@baxter.com

Results disclosure agreements

• Principal investigator is a sponsor employee Baxter's agreements with PIs may vary per requirements of the individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication or 1 year after study completion. Baxter requires a review of results communications (e.g., for confidential information) ≥90 days prior to submission or communication. Baxter may request an additional delay of ≤60 days (e.g., for intellectual property protection)
• Publication restrictions are in place

Restriction type: OTHER