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

Phase 3

Completed

Conditions: Face-lift
Facial Rhytidectomy

Interventions: Biological: FS VH S/D 4 s-apr

Registration Number: NCT00999141

Lead Sponsor: Baxter Healthcare Corporation

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 75

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FS VH S/D 4 s-apr	FS VH S/D 4 s-apr	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.

Primary Outcome Measures

Name	Time	Method
Total Volume of Drainage on Each Side of the Face	24 hours (± 4h) after surgery	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).
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

Name	Time	Method
Participants' First Occurrence of Hematoma or Seroma by Study Day	Day 0 (day of surgery) through postoperative day 14	Investigators assessed each side of the face for the presence of hematomas and/or seromas
Participants With Hematoma/Seroma by Study Day	Day 0 (day of surgery) through postoperative day 14	Investigators assessed each side of the face for the presence of hematoma and/or seroma
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	Through postoperative Day 1	Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema
Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 3	Through postoperative Day 3	Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema
Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 7	Through postoperative Day 7	Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema
Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 14	Through postoperative Day 14	Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema
Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14	Day 0 (preoperative) through postoperative Day 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).
Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14	Through postoperative 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?"
Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 1	Through postoperative 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?"
Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 3	Through postoperative 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?"
Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 7	Through postoperative 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?"
Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 14	Through postoperative 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?"
Reasons for Participants' Preferences for Side of Face	Through postoperative Day 14	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)