Trial Outcomes & Findings for Efficacy and Safety of FS VH S/D 4 S-apr for Flap Adherence in Rhytidectomy (NCT NCT00999141)

NCT ID: NCT00999141

Last Updated: 2012-10-08

Results Overview

Total drainage volume collected from each side of the face. One side of face is treated with FS VH S/D 4 s-apr (FS); the other side is treated using standard of care (SoC).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 75 participants
• Primary outcome timeframe: 24 hours (± 4h) after surgery
• Results posted on: 2012-10-08

Participant Flow

Patients were enrolled at 7 clinical sites in the United States, beginning September 2009 and completing in December 2009

79 participants were enrolled and screened. 2 were screen failures and 2 requested withdrawal. Therefore, 75 of the 79 enrolled were randomized.

Participant milestones

Measure	Facelift Participants One side of face will be treated with the investigational product (FS VH S/D 4 s-apr) as an adjuvant to the standard of care (SoC), and the other side of the face will receive SoC alone. Please note: Each subject will participate in both arms (investigational product and SoC) simultaneously, and will serve as his/her own control.
Overall Study STARTED	75
Overall Study COMPLETED	75
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of FS VH S/D 4 S-apr for Flap Adherence in Rhytidectomy

Baseline characteristics by cohort

Measure	Facelift Participants n=75 Participants One side of face will be treated with the investigational product (FS VH S/D 4 s-apr) as an adjuvant to the standard of care (SoC), and the other side of the face will receive SoC alone. Please note: Each subject will participate in both arms (investigational product and SoC) simultaneously, and will serve as his/her own control.
Age Continuous	54.4 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	75 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours (± 4h) after surgery

Population: Full Analysis Data Set = All randomized and treated participants

Total drainage volume collected from each side of the face. One side of face is treated with FS VH S/D 4 s-apr (FS); the other side is treated using standard of care (SoC).

Outcome measures

Measure	Standard of Care (SoC) n=75 Participants	FS VH S/D 4 S-apr n=75 Participants	Standard of Care (SoC) Side - Hematoma	Standard of Care (SoC) Side - Seroma	FS VH S/D 4 S-apr Side - Day 7	SoC Side - Day 7	FS VH S/D 4 S-apr Side - Day 14	SoC Side - Day 14
Total Volume of Drainage on Each Side of the Face	20.0 mL Interval 0.0 to 50.0	8.0 mL Interval 0.0 to 39.0	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 0 (day of surgery) through postoperative Day 14

Population: Safety Analysis Set

Outcome measures

Measure	Standard of Care (SoC) n=75 Participants	FS VH S/D 4 S-apr n=75 Participants	Standard of Care (SoC) Side - Hematoma	Standard of Care (SoC) Side - Seroma	FS VH S/D 4 S-apr Side - Day 7	SoC Side - Day 7	FS VH S/D 4 S-apr Side - Day 14	SoC Side - Day 14
Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr) non-Serious Adverse Events- Mild	0 Events	2 Events	—	—	—	—	—	—
Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr) Serious Adverse Events- Mild	0 Events	0 Events	—	—	—	—	—	—
Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr) Serious Adverse Events- Moderate	0 Events	1 Events	—	—	—	—	—	—
Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr) Serious Adverse Events- Severe	0 Events	0 Events	—	—	—	—	—	—
Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr) non-Serious Adverse Events- Moderate	0 Events	0 Events	—	—	—	—	—	—
Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr) non-Serious Adverse Events- Severe	0 Events	0 Events	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 0 (day of surgery) through postoperative day 14

Population: Full Analysis Data Set = All randomized and treated participants

Investigators assessed each side of the face for the presence of hematomas and/or seromas

Outcome measures

Measure	Standard of Care (SoC) n=75 Participants	FS VH S/D 4 S-apr n=75 Participants	Standard of Care (SoC) Side - Hematoma n=75 Participants	Standard of Care (SoC) Side - Seroma n=75 Participants	FS VH S/D 4 S-apr Side - Day 7	SoC Side - Day 7	FS VH S/D 4 S-apr Side - Day 14	SoC Side - Day 14
Participants' First Occurrence of Hematoma or Seroma by Study Day Day 0	0 participants	0 participants	1 participants	0 participants	—	—	—	—
Participants' First Occurrence of Hematoma or Seroma by Study Day Day 1	1 participants	2 participants	0 participants	1 participants	—	—	—	—
Participants' First Occurrence of Hematoma or Seroma by Study Day Day 2	0 participants	0 participants	0 participants	0 participants	—	—	—	—
Participants' First Occurrence of Hematoma or Seroma by Study Day Day 3	0 participants	1 participants	2 participants	2 participants	—	—	—	—
Participants' First Occurrence of Hematoma or Seroma by Study Day Day 4	0 participants	0 participants	0 participants	0 participants	—	—	—	—
Participants' First Occurrence of Hematoma or Seroma by Study Day Day 5	0 participants	0 participants	0 participants	0 participants	—	—	—	—
Participants' First Occurrence of Hematoma or Seroma by Study Day Day 6	0 participants	0 participants	0 participants	0 participants	—	—	—	—
Participants' First Occurrence of Hematoma or Seroma by Study Day Day 7	0 participants	1 participants	1 participants	1 participants	—	—	—	—
Participants' First Occurrence of Hematoma or Seroma by Study Day Day 8	0 participants	0 participants	0 participants	0 participants	—	—	—	—
Participants' First Occurrence of Hematoma or Seroma by Study Day Day 9	0 participants	0 participants	0 participants	0 participants	—	—	—	—
Participants' First Occurrence of Hematoma or Seroma by Study Day Day 10	0 participants	1 participants	0 participants	0 participants	—	—	—	—
Participants' First Occurrence of Hematoma or Seroma by Study Day Day 11	0 participants	0 participants	0 participants	0 participants	—	—	—	—
Participants' First Occurrence of Hematoma or Seroma by Study Day Day 12	0 participants	0 participants	0 participants	0 participants	—	—	—	—
Participants' First Occurrence of Hematoma or Seroma by Study Day Day 13	0 participants	0 participants	0 participants	0 participants	—	—	—	—
Participants' First Occurrence of Hematoma or Seroma by Study Day Day 14	0 participants	1 participants	0 participants	0 participants	—	—	—	—

SECONDARY outcome

Timeframe: Day 0 (day of surgery) through postoperative day 14

Population: Full Analysis Data Set = All randomized and treated participants

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

Outcome measures

Measure	Standard of Care (SoC) n=75 Participants	FS VH S/D 4 S-apr n=75 Participants	Standard of Care (SoC) Side - Hematoma	Standard of Care (SoC) Side - Seroma	FS VH S/D 4 S-apr Side - Day 7	SoC Side - Day 7	FS VH S/D 4 S-apr Side - Day 14	SoC Side - Day 14
Participants With Hematoma/Seroma by Study Day Day 0	0 participants	1 participants	—	—	—	—	—	—
Participants With Hematoma/Seroma by Study Day Day 1	3 participants	1 participants	—	—	—	—	—	—
Participants With Hematoma/Seroma by Study Day Day 2	2 participants	1 participants	—	—	—	—	—	—
Participants With Hematoma/Seroma by Study Day Day 3	2 participants	4 participants	—	—	—	—	—	—
Participants With Hematoma/Seroma by Study Day Day 4	1 participants	4 participants	—	—	—	—	—	—
Participants With Hematoma/Seroma by Study Day Day 5	0 participants	3 participants	—	—	—	—	—	—
Participants With Hematoma/Seroma by Study Day Day 6	0 participants	0 participants	—	—	—	—	—	—
Participants With Hematoma/Seroma by Study Day Day 7	1 participants	2 participants	—	—	—	—	—	—
Participants With Hematoma/Seroma by Study Day Day 8	1 participants	2 participants	—	—	—	—	—	—
Participants With Hematoma/Seroma by Study Day Day 9	1 participants	2 participants	—	—	—	—	—	—
Participants With Hematoma/Seroma by Study Day Day 10	2 participants	2 participants	—	—	—	—	—	—
Participants With Hematoma/Seroma by Study Day Day 11	0 participants	1 participants	—	—	—	—	—	—
Participants With Hematoma/Seroma by Study Day Day 12	0 participants	1 participants	—	—	—	—	—	—
Participants With Hematoma/Seroma by Study Day Day 13	0 participants	1 participants	—	—	—	—	—	—
Participants With Hematoma/Seroma by Study Day Day 14	1 participants	1 participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 0 (day of surgery) through postoperative Day 14

Population: Full Analysis Data Set = All randomized and treated participants

Outcome measures

Measure	Standard of Care (SoC) n=75 Participants	FS VH S/D 4 S-apr n=75 Participants	Standard of Care (SoC) Side - Hematoma n=75 Participants	Standard of Care (SoC) Side - Seroma n=75 Participants	FS VH S/D 4 S-apr Side - Day 7	SoC Side - Day 7	FS VH S/D 4 S-apr Side - Day 14	SoC Side - Day 14
Number of Participants With Hematoma/Seroma Anytime During the Study	2 participants	5 participants	3 participants	65 participants	—	—	—	—

SECONDARY outcome

Timeframe: Through postoperative Day 1

Population: Full Analysis Data Set = All randomized and treated participants

Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema

Outcome measures

Measure	Standard of Care (SoC) n=75 Participants	FS VH S/D 4 S-apr n=75 Participants	Standard of Care (SoC) Side - Hematoma n=75 Participants	Standard of Care (SoC) Side - Seroma	FS VH S/D 4 S-apr Side - Day 7	SoC Side - Day 7	FS VH S/D 4 S-apr Side - Day 14	SoC Side - Day 14
Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 1	40 participants	12 participants	23 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Through postoperative Day 3

Population: Full Analysis Data Set = All randomized and treated participants

Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema

Outcome measures

Measure	Standard of Care (SoC) n=75 Participants	FS VH S/D 4 S-apr n=75 Participants	Standard of Care (SoC) Side - Hematoma n=75 Participants	Standard of Care (SoC) Side - Seroma	FS VH S/D 4 S-apr Side - Day 7	SoC Side - Day 7	FS VH S/D 4 S-apr Side - Day 14	SoC Side - Day 14
Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 3	41 participants	12 participants	22 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Through postoperative Day 7

Population: Full Analysis Data Set = All randomized and treated participants

Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema

Outcome measures

Measure	Standard of Care (SoC) n=73 Participants	FS VH S/D 4 S-apr n=73 Participants	Standard of Care (SoC) Side - Hematoma n=73 Participants	Standard of Care (SoC) Side - Seroma	FS VH S/D 4 S-apr Side - Day 7	SoC Side - Day 7	FS VH S/D 4 S-apr Side - Day 14	SoC Side - Day 14
Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 7	41 participants	15 participants	17 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Through postoperative Day 14

Population: Full Analysis Data Set = All randomized and treated participants

Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema

Outcome measures

Measure	Standard of Care (SoC) n=74 Participants	FS VH S/D 4 S-apr n=74 Participants	Standard of Care (SoC) Side - Hematoma n=74 Participants	Standard of Care (SoC) Side - Seroma	FS VH S/D 4 S-apr Side - Day 7	SoC Side - Day 7	FS VH S/D 4 S-apr Side - Day 14	SoC Side - Day 14
Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 14	27 participants	13 participants	34 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 0 (preoperative) through postoperative Day 14

Population: Full Analysis Data Set = All randomized and treated participants

Skin sensitivity was measured using Semmes-Weinstein Monofilament set to detect neurological damage. Filament sizes are noted by handle numbers of measuring tools ([handle number = log10(10*force in milligrams applied to skin)], range = 1.65 to 6.65). Detection of filament with smaller handle number = greater skin sensitivity. Smaller change in filament size detection from pre-op to post-op = less impact to recovery of sensation. Smallest filament felt for each side of face was noted. Change in skin sensitivity computed as (Handle Number Postop Day 3, 7, or 14) - (Handle Number Preop Day 0).

Outcome measures

Measure	Standard of Care (SoC) n=75 Participants	FS VH S/D 4 S-apr n=75 Participants	Standard of Care (SoC) Side - Hematoma	Standard of Care (SoC) Side - Seroma	FS VH S/D 4 S-apr Side - Day 7	SoC Side - Day 7	FS VH S/D 4 S-apr Side - Day 14	SoC Side - Day 14
Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14 Day 14	0.24 Handle number(s) 95% Confidence Interval 0.82 • Interval 0.05 to 0.42	0.32 Handle number(s) 95% Confidence Interval 0.96 • Interval 0.1 to 0.54	—	—	—	—	—	—
Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14 Day 3	0.54 Handle number(s) 95% Confidence Interval 0.85 • Interval 0.34 to 0.73	0.60 Handle number(s) 95% Confidence Interval 0.94 • Interval 0.39 to 0.82	—	—	—	—	—	—
Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14 Day 7	0.44 Handle number(s) 95% Confidence Interval 0.94 • Interval 0.22 to 0.65	0.51 Handle number(s) 95% Confidence Interval 1.02 • Interval 0.27 to 0.74	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through postoperative Day 14

Population: Full Analysis Data Set = All randomized and treated participants

Participants responded to the following question during the side of face preference assessment:

"Which side of the face do you prefer? Left side, right side, or no preference?"

Outcome measures

Measure	Standard of Care (SoC) n=75 Participants	FS VH S/D 4 S-apr n=75 Participants	Standard of Care (SoC) Side - Hematoma n=75 Participants	Standard of Care (SoC) Side - Seroma	FS VH S/D 4 S-apr Side - Day 7	SoC Side - Day 7	FS VH S/D 4 S-apr Side - Day 14	SoC Side - Day 14
Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14 Day 1 (n= 75)	47 participants	16 participants	12 participants	—	—	—	—	—
Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14 Day 3 (n= 75)	40 participants	23 participants	12 participants	—	—	—	—	—
Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14 Day 7 (n= 75)	44 participants	18 participants	13 participants	—	—	—	—	—
Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14 Day 14 (n= 74)	42 participants	15 participants	17 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Through postoperative Day 1

Population: Full Analysis Data Set = All randomized and treated participants

Participants responded to the following question during the side of face preference assessment:

"Which side of the face do you prefer? Left side, right side, or no preference?"

Outcome measures

Measure	Standard of Care (SoC) n=75 Participants	FS VH S/D 4 S-apr n=75 Participants	Standard of Care (SoC) Side - Hematoma	Standard of Care (SoC) Side - Seroma	FS VH S/D 4 S-apr Side - Day 7	SoC Side - Day 7	FS VH S/D 4 S-apr Side - Day 14	SoC Side - Day 14
Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 1	0.63 Proportion of Participants	0.21 Proportion of Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through postoperative Day 3

Population: Full Analysis Data Set = All randomized and treated participants

Participants responded to the following question during the side of face preference assessment:

"Which side of the face do you prefer? Left side, right side, or no preference?"

Outcome measures

Measure	Standard of Care (SoC) n=75 Participants	FS VH S/D 4 S-apr n=75 Participants	Standard of Care (SoC) Side - Hematoma	Standard of Care (SoC) Side - Seroma	FS VH S/D 4 S-apr Side - Day 7	SoC Side - Day 7	FS VH S/D 4 S-apr Side - Day 14	SoC Side - Day 14
Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 3	0.53 Proportion of Participants	0.31 Proportion of Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through postoperative Day 7

Population: Full Analysis Data Set = All randomized and treated participants

Participants responded to the following question during the side of face preference assessment:

"Which side of the face do you prefer? Left side, right side, or no preference?"

Outcome measures

Measure	Standard of Care (SoC) n=75 Participants	FS VH S/D 4 S-apr n=75 Participants	Standard of Care (SoC) Side - Hematoma	Standard of Care (SoC) Side - Seroma	FS VH S/D 4 S-apr Side - Day 7	SoC Side - Day 7	FS VH S/D 4 S-apr Side - Day 14	SoC Side - Day 14
Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 7	0.59 Proportion of Participants	0.24 Proportion of Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through postoperative Day 14

Population: Full Analysis Data Set = All randomized and treated participants

Participants responded to the following question during the side of face preference assessment:

"Which side of the face do you prefer? Left side, right side, or no preference?"

Outcome measures

Measure	Standard of Care (SoC) n=74 Participants	FS VH S/D 4 S-apr n=74 Participants	Standard of Care (SoC) Side - Hematoma	Standard of Care (SoC) Side - Seroma	FS VH S/D 4 S-apr Side - Day 7	SoC Side - Day 7	FS VH S/D 4 S-apr Side - Day 14	SoC Side - Day 14
Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 14	0.57 Proportion of Participants	0.20 Proportion of Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through postoperative Day 14

Population: Full Analysis Data Set = All randomized and treated participants

Participants responded to the following questions during the side of face preference assessment:

1. "Which side of the face do you prefer? Left side, right side, or no preference?"

2. If "right" or "left" is chosen, participants were asked "Please mark ALL reasons for choosing this side"

1. Better skin sensation

2. Less numbness

3. Looks better

4. Less bruising

5. Less swelling

6. Less pain

7. Less itching

8. Less tingling

9. Less feeling of "pins and needles"

10. Other ________________ (Free Text)

Outcome measures

Measure	Standard of Care (SoC) n=47 Participants	FS VH S/D 4 S-apr n=16 Participants	Standard of Care (SoC) Side - Hematoma n=40 Participants	Standard of Care (SoC) Side - Seroma n=23 Participants	FS VH S/D 4 S-apr Side - Day 7 n=44 Participants	SoC Side - Day 7 n=18 Participants	FS VH S/D 4 S-apr Side - Day 14 n=42 Participants	SoC Side - Day 14 n=15 Participants
Reasons for Participants' Preferences for Side of Face Better Skin Sensation	19 Participants	5 Participants	15 Participants	4 Participants	19 Participants	7 Participants	26 Participants	6 Participants
Reasons for Participants' Preferences for Side of Face Less Bruising	21 Participants	8 Participants	21 Participants	14 Participants	30 Participants	9 Participants	29 Participants	5 Participants
Reasons for Participants' Preferences for Side of Face Less Feeling of Pins and Needles	4 Participants	1 Participants	7 Participants	1 Participants	8 Participants	1 Participants	11 Participants	1 Participants
Reasons for Participants' Preferences for Side of Face Less Itching	2 Participants	2 Participants	7 Participants	3 Participants	9 Participants	1 Participants	11 Participants	0 Participants
Reasons for Participants' Preferences for Side of Face Less Numbness	16 Participants	6 Participants	24 Participants	9 Participants	24 Participants	7 Participants	28 Participants	11 Participants
Reasons for Participants' Preferences for Side of Face Less Pain	23 Participants	7 Participants	22 Participants	8 Participants	26 Participants	5 Participants	25 Participants	4 Participants
Reasons for Participants' Preferences for Side of Face Less Swelling	37 Participants	14 Participants	30 Participants	16 Participants	33 Participants	14 Participants	36 Participants	12 Participants
Reasons for Participants' Preferences for Side of Face Less Tingling	2 Participants	1 Participants	6 Participants	3 Participants	9 Participants	2 Participants	16 Participants	1 Participants
Reasons for Participants' Preferences for Side of Face Looks Better	35 Participants	13 Participants	32 Participants	19 Participants	37 Participants	13 Participants	35 Participants	12 Participants
Reasons for Participants' Preferences for Side of Face Other	3 Participants	0 Participants	3 Participants	1 Participants	3 Participants	0 Participants	2 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Through postoperative Day 14

Population: Full Analysis Data Set = All randomized and treated participants

During each postoperative visit (Day 1, 3, 7, and 14), participants were asked:

How would you rate your numbness on each side of your face on a scale of 0-10, with 10 being the worst numbness possible?

Difference in scores on a scale = (SoC score) - (FS VH S/D 4 s-apr score)

The planned and approved Statistical Analysis Plan (SAP) called for 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	Standard of Care (SoC) n=75 Participants	FS VH S/D 4 S-apr	Standard of Care (SoC) Side - Hematoma	Standard of Care (SoC) Side - Seroma	FS VH S/D 4 S-apr Side - Day 7	SoC Side - Day 7	FS VH S/D 4 S-apr Side - Day 14	SoC Side - Day 14
Participants' Assessment of Difference in Numbness Between Two Sides of Face Postoperative Day 1	0.3 Scores on a scale Standard Deviation 2.0	—	—	—	—	—	—	—
Participants' Assessment of Difference in Numbness Between Two Sides of Face Postoperative Day 3	0.4 Scores on a scale Standard Deviation 1.7	—	—	—	—	—	—	—
Participants' Assessment of Difference in Numbness Between Two Sides of Face Postoperative Day 7	0.3 Scores on a scale Standard Deviation 1.4	—	—	—	—	—	—	—
Participants' Assessment of Difference in Numbness Between Two Sides of Face Postoperative Day 14	0.5 Scores on a scale Standard Deviation 1.4	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Through postoperative Day 14

Population: Full Analysis Data Set = All randomized and treated participants

Investigator reported outcomes data was collected for overall preference for 1 side of face

Outcome measures

Measure	Standard of Care (SoC) n=75 Participants	FS VH S/D 4 S-apr n=75 Participants	Standard of Care (SoC) Side - Hematoma n=75 Participants	Standard of Care (SoC) Side - Seroma n=75 Participants	FS VH S/D 4 S-apr Side - Day 7 n=75 Participants	SoC Side - Day 7	FS VH S/D 4 S-apr Side - Day 14	SoC Side - Day 14
Investigator Preference for Side of Face Postoperative Day 1	8 participants	33 participants	21 participants	13 participants	0 participants	—	—	—
Investigator Preference for Side of Face Postoperative Day 3	7 participants	37 participants	18 participants	10 participants	3 participants	—	—	—
Investigator Preference for Side of Face Postoperative Day 7	16 participants	31 participants	16 participants	11 participants	1 participants	—	—	—
Investigator Preference for Side of Face Postoperative Day 14	16 participants	21 participants	25 participants	12 participants	1 participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Through postoperative Day 14

Population: Full Analysis Data Set = All randomized and treated participants

During postoperative visits investigators recorded their satisfaction with the quality of flap adherence for each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face)

Outcome measures

Measure	Standard of Care (SoC) n=75 Participants	FS VH S/D 4 S-apr n=75 Participants	Standard of Care (SoC) Side - Hematoma n=75 Participants	Standard of Care (SoC) Side - Seroma n=75 Participants	FS VH S/D 4 S-apr Side - Day 7 n=75 Participants	SoC Side - Day 7	FS VH S/D 4 S-apr Side - Day 14	SoC Side - Day 14
Investigators' Satisfaction With Quality of Flap Adherence Satisfaction with flap adherence FS Side- Day 1	1 participants	0 participants	8 participants	19 participants	47 participants	—	—	—
Investigators' Satisfaction With Quality of Flap Adherence Satisfaction with flap adherence FS Side- Day 3	0 participants	1 participants	6 participants	18 participants	50 participants	—	—	—
Investigators' Satisfaction With Quality of Flap Adherence Satisfaction with flap adherence FS Side- Day 7	0 participants	0 participants	1 participants	14 participants	60 participants	—	—	—
Investigators' Satisfaction With Quality of Flap Adherence Satisfaction with flap adherence FS Side- Day 14	0 participants	0 participants	1 participants	12 participants	62 participants	—	—	—
Investigators' Satisfaction With Quality of Flap Adherence Satisfaction with flap adherence SoC Side- Day 1	0 participants	7 participants	13 participants	26 participants	29 participants	—	—	—
Investigators' Satisfaction With Quality of Flap Adherence Satisfaction with flap adherence SoC Side- Day 3	0 participants	1 participants	23 participants	13 participants	38 participants	—	—	—
Investigators' Satisfaction With Quality of Flap Adherence Satisfaction with flap adherence SoC Side- Day 7	0 participants	0 participants	11 participants	25 participants	39 participants	—	—	—
Investigators' Satisfaction With Quality of Flap Adherence Satisfaction with flap adherence SoC Side- Day 14	0 participants	0 participants	5 participants	21 participants	49 participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Through postoperative Day 14

Population: Full Analysis Data Set = All randomized and treated participants

During postoperative visits investigators recorded their satisfaction with the rate of healing of each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face)

Outcome measures

Measure	Standard of Care (SoC) n=75 Participants	FS VH S/D 4 S-apr n=75 Participants	Standard of Care (SoC) Side - Hematoma n=75 Participants	Standard of Care (SoC) Side - Seroma n=75 Participants	FS VH S/D 4 S-apr Side - Day 7 n=75 Participants	SoC Side - Day 7	FS VH S/D 4 S-apr Side - Day 14	SoC Side - Day 14
Investigators' Satisfaction With Rate of Healing Satisfaction with Rate of Healing FS Side- Day 1	1 participants	0 participants	10 participants	28 participants	36 participants	—	—	—
Investigators' Satisfaction With Rate of Healing Satisfaction with Rate of Healing FS Side- Day 3	0 participants	0 participants	7 participants	19 participants	49 participants	—	—	—
Investigators' Satisfaction With Rate of Healing Satisfaction with Rate of Healing FS Side- Day 7	0 participants	0 participants	1 participants	14 participants	60 participants	—	—	—
Investigators' Satisfaction With Rate of Healing Satisfaction with Rate of Healing FS Side- Day 14	0 participants	0 participants	2 participants	11 participants	62 participants	—	—	—
Investigators' Satisfaction With Rate of Healing Satisfaction with Rate of Healing SoC Side- Day 1	0 participants	6 participants	14 participants	21 participants	34 participants	—	—	—
Investigators' Satisfaction With Rate of Healing Satisfaction with Rate of Healing SoC Side- Day 3	0 participants	1 participants	17 participants	17 participants	40 participants	—	—	—
Investigators' Satisfaction With Rate of Healing Satisfaction with Rate of Healing SoC Side- Day 7	0 participants	0 participants	11 participants	24 participants	40 participants	—	—	—
Investigators' Satisfaction With Rate of Healing Satisfaction with Rate of Healing SoC Side- Day 14	0 participants	0 participants	6 participants	20 participants	49 participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Through postoperative Day 14

Population: Full Analysis Data Set = All randomized and treated participants

During postoperative visits investigators recorded their satisfaction with treatment on each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face)

Outcome measures

Measure	Standard of Care (SoC) n=75 Participants	FS VH S/D 4 S-apr n=75 Participants	Standard of Care (SoC) Side - Hematoma n=75 Participants	Standard of Care (SoC) Side - Seroma n=75 Participants	FS VH S/D 4 S-apr Side - Day 7 n=75 Participants	SoC Side - Day 7	FS VH S/D 4 S-apr Side - Day 14	SoC Side - Day 14
Investigators' Satisfaction With Treatment Satisfaction with Treatment on FS Side- Day 1	1 participants	0 participants	7 participants	19 participants	48 participants	—	—	—
Investigators' Satisfaction With Treatment Satisfaction with Treatment on FS Side- Day 3	0 participants	1 participants	5 participants	13 participants	56 participants	—	—	—
Investigators' Satisfaction With Treatment Satisfaction with Treatment on FS Side- Day 7	0 participants	0 participants	2 participants	12 participants	61 participants	—	—	—
Investigators' Satisfaction With Treatment Satisfaction with Treatment on FS Side- Day 14	0 participants	0 participants	2 participants	10 participants	63 participants	—	—	—
Investigators' Satisfaction With Treatment Satisfaction with Treatment on SoC Side- Day 1	0 participants	6 participants	15 participants	17 participants	37 participants	—	—	—
Investigators' Satisfaction With Treatment Satisfaction with Treatment on SoC Side- Day 3	0 participants	2 participants	14 participants	16 participants	43 participants	—	—	—
Investigators' Satisfaction With Treatment Satisfaction with Treatment on SoC Side- Day 7	0 participants	0 participants	11 participants	19 participants	45 participants	—	—	—
Investigators' Satisfaction With Treatment Satisfaction with Treatment on SoC Side- Day 14	0 participants	0 participants	5 participants	19 participants	51 participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Through postoperative Day 14

Population: Full Analysis Data Set = All randomized and treated participants

Outcome measures

Measure	Standard of Care (SoC) n=75 Participants	FS VH S/D 4 S-apr n=75 Participants	Standard of Care (SoC) Side - Hematoma n=75 Participants	Standard of Care (SoC) Side - Seroma n=75 Participants	FS VH S/D 4 S-apr Side - Day 7 n=75 Participants	SoC Side - Day 7	FS VH S/D 4 S-apr Side - Day 14	SoC Side - Day 14
Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr Day 1	0 participants	0 participants	8 participants	20 participants	47 participants	—	—	—
Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr Day 3	0 participants	0 participants	6 participants	26 participants	43 participants	—	—	—
Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr Day 7	0 participants	0 participants	5 participants	20 participants	50 participants	—	—	—
Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr Day 14	0 participants	0 participants	8 participants	14 participants	53 participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Through postoperative Day 14

Population: Full Analysis Data Set = All randomized and treated participants

Outcome measures

Measure	Standard of Care (SoC) n=1 Participants	FS VH S/D 4 S-apr n=4 Participants	Standard of Care (SoC) Side - Hematoma n=3 Participants	Standard of Care (SoC) Side - Seroma n=3 Participants	FS VH S/D 4 S-apr Side - Day 7	SoC Side - Day 7	FS VH S/D 4 S-apr Side - Day 14	SoC Side - Day 14
Total Aspiration Volumes From Hematomas and Seromas	NA mL Interval 1.0 to 1.0 The median is the central value of a series of numbers. This arm has a single data point, i.e. no series of numbers from which to determine a central value.	4.1 mL Interval 2.5 to 8.0	4.7 mL Interval 3.0 to 12.5	7.0 mL Interval 4.7 to 16.5	—	—	—	—

Adverse Events

Localized to SoC Side of Face

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Localized to FS VH S/D 4 S-apr Side of Face

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Non-localized AEs

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Localized to SoC Side of Face n=75 participants at risk AE was localized to the side of the face which was treated with standard of care (SoC).	Localized to FS VH S/D 4 S-apr Side of Face n=75 participants at risk AE was localized to the side of the face which was treated with FS VH S/D 4 s-apr	Non-localized AEs n=75 participants at risk AE affected a site other than either side of the face (ie, non-localized AE)
Infections and infestations Wound abscess	0.00% 0/75 • Day 0 (day of surgery) through postoperative Day 14	1.3% 1/75 • Number of events 1 • Day 0 (day of surgery) through postoperative Day 14	0.00% 0/75 • Day 0 (day of surgery) through postoperative Day 14
Metabolism and nutrition disorders Dehydration	0.00% 0/75 • Day 0 (day of surgery) through postoperative Day 14	0.00% 0/75 • Day 0 (day of surgery) through postoperative Day 14	1.3% 1/75 • Number of events 1 • Day 0 (day of surgery) through postoperative Day 14

Other adverse events

Measure	Localized to SoC Side of Face n=75 participants at risk AE was localized to the side of the face which was treated with standard of care (SoC).	Localized to FS VH S/D 4 S-apr Side of Face n=75 participants at risk AE was localized to the side of the face which was treated with FS VH S/D 4 s-apr	Non-localized AEs n=75 participants at risk AE affected a site other than either side of the face (ie, non-localized AE)
Injury, poisoning and procedural complications Post procedural haematoma	5.3% 4/75 • Number of events 4 • Day 0 (day of surgery) through postoperative Day 14	1.3% 1/75 • Number of events 1 • Day 0 (day of surgery) through postoperative Day 14	0.00% 0/75 • Day 0 (day of surgery) through postoperative Day 14
Injury, poisoning and procedural complications Seroma	5.3% 4/75 • Number of events 4 • Day 0 (day of surgery) through postoperative Day 14	5.3% 4/75 • Number of events 6 • Day 0 (day of surgery) through postoperative Day 14	0.00% 0/75 • Day 0 (day of surgery) through postoperative Day 14

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