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

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the safety and efficacy of FS VH S/D 4 s-apr versus standard of care in adhering tissue and improving wound healing in subjects undergoing facelift.

Official Title
-----------------
A Randomized, Controlled Phase 3 Study to Evaluate Safety and Efficacy of Fibrin Sealant (FS) VH S/D 4 S-apr (ARTISS) to Adhere Tissues and Improve Wound Healing in Subjects Undergoing Rhytidectomy (Facelift)

Conditions
-----------------
Face-lift, Facial Rhytidectomy

Intervention / Treatment
-----------------
* Biological: FS VH S/D 4 s-apr


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subject is 18 to 75 years of age at the time of screening Subject is planned for facial rhytidectomy Subject has read, understood and signed the written informed consent Subject is healthy, as determined by the investigator using standard pre-operative assessments to include laboratory tests and electrocardiograms Subject is of childbearing potential, presents with a negative serum pregnancy test, and agrees to employ adequate birth control measures for the duration of the study Subject is willing and able to comply with the requirements of the protocol Exclusion Criteria: Subject is indicated for an abbreviated or modified face-lift procedure such as deep plane procedures, minimal undermining procedures, thread lifts, and minimal access cranial suspension Subject is indicated for concurrent facial surgeries during the operation (eg forehead plasty,blepharoplasty, rhinoplasty, buccal fat removal, any filler injections including fat injections, lip augmentation, skin resurfacing procedures etc.) Subject is indicated for additional procedures to the body during the same operation (eg liposuction, mastoplasty etc.) Subject has undergone a prior rhytidectomy surgery Subject is an active smoker, as assessed by the investigator Subject has a known (documented) bleeding or coagulation disorder Subject is being treated with anti-coagulants or with Aspirin (that was not discontinued 7 days prior to surgery) Subject has a vascular disorder, cardiovascular disease, and/or uncontrolled hypertension Subject has diabetes mellitus with glycosylated hemoglobin (HbA1c) > 7 Subject is receiving active treatment for a malignancy Subject has a connective tissue disorder Subject has an active or chronic skin disorder Subject has history of Bell's palsy Subject has a documented history of pathologically or pharmacologically induced immune deficiency Subject has received chronic treatment with immunosuppressive drugs, systemic corticosteroids, or other chronic treatments within 30 days prior to the surgery Subject has a known sensitivity to components of FS VH S/D 4 s-apr Subject has a known psychiatric disorder (eg, obsessive compulsive disorder, anxiety, eating disorders, etc.) Subject has documented healing complications following previous surgeries (eg, hypertrophic scarring) Subject is pregnant or lactating at the time of enrollment Subject has participated in another clinical study involving an investigational product/device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational product/device during the course of this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FS VH S/D 4 s-apr<br>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. Please note: Each subject will participate in both arms (investigational product and standard of care) simultaneously, and will serve as his/her own control. | Biological: FS VH S/D 4 s-apr<br>* FS VH S/D 4 s-apr will be applied (using spray device provided by Sponsor) to the subcutaneous plane (intraoperative, topical administration) in both the neck and the face area.<br>* Other names: ARTISS;|
| No Intervention: Standard of Care (SoC)<br>Other side of face will receive standard of care. Please note: Each subject will participate in both arms (investigational product and standard of care) simultaneously, and will serve as his/her own control. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Volume of Drainage on Each Side of the Face | 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). | 24 hours (± 4h) after surgery | 
| Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr) |  | Day 0 (day of surgery) through postoperative Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants' First Occurrence of Hematoma or Seroma by Study Day | Investigators assessed each side of the face for the presence of hematomas and/or seromas | Day 0 (day of surgery) through postoperative day 14 | 
| Participants With Hematoma/Seroma by Study Day | Investigators assessed each side of the face for the presence of hematoma and/or seroma | Day 0 (day of surgery) through postoperative day 14 | 
| Number of Participants With Hematoma/Seroma Anytime During the Study |  | Day 0 (day of surgery) through postoperative Day 14 | 
| Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 1 | Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema | Through postoperative Day 1 | 
| Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 3 | Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema | Through postoperative Day 3 | 
| Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 7 | Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema | Through postoperative Day 7 | 
| Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 14 | Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema | Through postoperative Day 14 | 
| Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14 | 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). | Day 0 (preoperative) through postoperative Day 14 | 
| Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14 | 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? | Through postoperative Day 14 | 
| Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 1 | 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? | Through postoperative Day 1 | 
| Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 3 | 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? | Through postoperative Day 3 | 
| Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 7 | 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? | Through postoperative Day 7 | 
| Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 14 | 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? | Through postoperative Day 14 | 
| Reasons for Participants' Preferences for Side of Face | Participants responded to the following questions during the side of face preference assessment: Which side of the face do you prefer? Left side, right side, or no preference? If right or left is chosen, participants were asked Please mark ALL reasons for choosing this side Better skin sensation Less numbness Looks better Less bruising Less swelling Less pain Less itching Less tingling Less feeling of pins and needles Other ________________ (Free Text) | Through postoperative Day 14 |