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

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)

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.

Study Overview

• Status: Completed
• Conditions: Face-lift; Facial Rhytidectomy
• Intervention / Treatment: Biological: FS VH S/D 4 s-apr

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States
  • Georgia
    • Atlanta, Georgia, United States
    • Evans, Georgia, United States
  • New York
    • Hewlett, New York, United States
  • Tennessee
    • Chattanooga, Tennessee, United States
  • Texas
    • Dallas, Texas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: FS VH S/D 4 s-apr; 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.; Other Names: ARTISS
No Intervention: Standard of Care (SoC); 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 sensationLess numbnessLooks betterLess bruisingLess swellingLess painLess itchingLess tinglingLess feeling of "pins and needles"Other ________________ (Free Text)	Through postoperative Day 14

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants' Assessment of Difference in Numbness Between Two Sides of Face	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.	Through postoperative Day 14
Investigator Preference for Side of Face	Investigator reported outcomes data was collected for overall preference for 1 side of face	Through postoperative Day 14
Investigators' Satisfaction With Quality of Flap Adherence	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)	Through postoperative Day 14
Investigators' Satisfaction With Rate of Healing	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)	Through postoperative Day 14
Investigators' Satisfaction With Treatment	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)	Through postoperative Day 14
Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr		Through postoperative Day 14
Total Aspiration Volumes From Hematomas and Seromas		Through postoperative Day 14

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Hester TR Jr, Shire JR, Nguyen DB, Gerut ZE, Chen AH, Diamond J, Desmond JC, Silvati-Fidell L, Abrams SZ, Rohrich RJ. Randomized, controlled, phase 3 study to evaluate the safety and efficacy of fibrin sealant VH S/D 4 s-apr (Artiss) to improve tissue adherence in subjects undergoing rhytidectomy. Aesthet Surg J. 2013 May;33(4):487-96. doi: 10.1177/1090820X13479969. Epub 2013 Apr 5.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: October 20, 2009
• First Submitted That Met QC Criteria: October 20, 2009
• First Posted (Estimate): October 21, 2009

Study Record Updates

• Last Update Posted (Estimate): October 8, 2012
• Last Update Submitted That Met QC Criteria: October 4, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 550901