Clinical trial NCT00999141: Efficacy and Safety of FS VH S/D 4 S-apr for Flap Adherence in Rhytidectomy
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Face-lift
Facial Rhytidectomy
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2009-10-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Total Volume of Drainage on Each Side of the Face
timeFrame: 24 hours (± 4h) after surgery
measure: Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr)
timeFrame: Day 0 (day of surgery) through postoperative Day 14
Secondary outcomes:
measure: Participants' First Occurrence of Hematoma or Seroma by Study Day
timeFrame: Day 0 (day of surgery) through postoperative day 14
measure: Participants With Hematoma/Seroma by Study Day
timeFrame: Day 0 (day of surgery) through postoperative day 14
measure: Number of Participants With Hematoma/Seroma Anytime During the Study
timeFrame: Day 0 (day of surgery) through postoperative Day 14
measure: Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 1
timeFrame: Through postoperative Day 1
measure: Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 3
timeFrame: Through postoperative Day 3
measure: Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 7
timeFrame: Through postoperative Day 7
measure: Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 14
timeFrame: Through postoperative Day 14
measure: Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14
timeFrame: Day 0 (preoperative) through postoperative Day 14
measure: Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14
timeFrame: Through postoperative Day 14
measure: Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 1
timeFrame: Through postoperative Day 1
measure: Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 3
timeFrame: Through postoperative Day 3
measure: Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 7
timeFrame: Through postoperative Day 7
measure: Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 14
timeFrame: Through postoperative Day 14
measure: Reasons for Participants' Preferences for Side of Face
timeFrame: Through postoperative Day 14
Other outcomes:
measure: Participants' Assessment of Difference in Numbness Between Two Sides of Face
timeFrame: Through postoperative Day 14
measure: Investigator Preference for Side of Face
timeFrame: Through postoperative Day 14
measure: Investigators' Satisfaction With Quality of Flap Adherence
timeFrame: Through postoperative Day 14
measure: Investigators' Satisfaction With Rate of Healing
timeFrame: Through postoperative Day 14
measure: Investigators' Satisfaction With Treatment
timeFrame: Through postoperative Day 14
measure: Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr
timeFrame: Through postoperative Day 14
measure: Total Aspiration Volumes From Hematomas and Seromas
timeFrame: Through postoperative Day 14
Locations:
city: Beverly Hills
country: United States
state: California
city: Atlanta
country: United States
state: Georgia
city: Evans
country: United States
state: Georgia
city: Hewlett
country: United States
state: New York
city: Chattanooga
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
Study officials:
affiliation: Baxter Healthcare Corporation
name: Steve Z Abrams, MD
role: STUDY_DIRECTOR
References:
citation: 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.