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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00999141
First received: October 20, 2009
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Face-lift
Facial Rhytidectomy
Biological: FS VH S/D 4 s-apr
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Total Volume of Drainage on Each Side of the Face [ Time Frame: 24 hours (± 4h) after surgery ] [ Designated as safety issue: No ]
    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) [ Time Frame: Day 0 (day of surgery) through postoperative Day 14 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Participants' First Occurrence of Hematoma or Seroma by Study Day [ Time Frame: Day 0 (day of surgery) through postoperative day 14 ] [ Designated as safety issue: No ]
    Investigators assessed each side of the face for the presence of hematomas and/or seromas

  • Participants With Hematoma/Seroma by Study Day [ Time Frame: Day 0 (day of surgery) through postoperative day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 0 (day of surgery) through postoperative Day 14 ] [ Designated as safety issue: No ]
  • Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 1 [ Time Frame: Through postoperative Day 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Through postoperative Day 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Through postoperative Day 7 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Through postoperative Day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 0 (preoperative) through postoperative Day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Through postoperative Day 14 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Through postoperative Day 1 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Through postoperative Day 3 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Through postoperative Day 7 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Through postoperative Day 14 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Through postoperative Day 14 ] [ Designated as safety issue: No ]

    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)


Other Outcome Measures:
  • Participants' Assessment of Difference in Numbness Between Two Sides of Face [ Time Frame: Through postoperative Day 14 ] [ Designated as safety issue: No ]

    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.


  • Investigator Preference for Side of Face [ Time Frame: Through postoperative Day 14 ] [ Designated as safety issue: No ]
    Investigator reported outcomes data was collected for overall preference for 1 side of face

  • Investigators' Satisfaction With Quality of Flap Adherence [ Time Frame: Through postoperative Day 14 ] [ Designated as safety issue: No ]
    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)

  • Investigators' Satisfaction With Rate of Healing [ Time Frame: Through postoperative Day 14 ] [ Designated as safety issue: No ]
    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)

  • Investigators' Satisfaction With Treatment [ Time Frame: Through postoperative Day 14 ] [ Designated as safety issue: No ]
    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)

  • Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr [ Time Frame: Through postoperative Day 14 ] [ Designated as safety issue: No ]
  • Total Aspiration Volumes From Hematomas and Seromas [ Time Frame: Through postoperative Day 14 ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: September 2009
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999141

Locations
United States, California
Beverly Hills, California, United States
United States, Georgia
Atlanta, Georgia, United States
Evans, Georgia, United States
United States, New York
Hewlett, New York, United States
United States, Tennessee
Chattanooga, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Steve Z Abrams, MD Baxter Healthcare Corporation
  More Information

No publications provided by Baxter Healthcare Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00999141     History of Changes
Other Study ID Numbers: 550901
Study First Received: October 20, 2009
Results First Received: October 6, 2011
Last Updated: October 4, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 29, 2014