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

NCT00999141 | Completed Phase 3 Results

• 1 other identifier: 550901
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 6

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.

Conditions

Face-lift; Facial Rhytidectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Participants' First Occurrence of Hematoma or Seroma by Study Day

  Day 0 (day of surgery) through postoperative day 14

• Participants With Hematoma/Seroma by Study Day

  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

  Through postoperative Day 1

• Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 3

  Through postoperative Day 3

Other Outcomes (7)

• Participants' Assessment of Difference in Numbness Between Two Sides of Face

  Through postoperative Day 14

• Investigator Preference for Side of Face

  Through postoperative Day 14

• Investigators' Satisfaction With Quality of Flap Adherence

  Through postoperative Day 14

Study Arms (2)

FS VH S/D 4 s-apr

EXPERIMENTAL

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

Standard of Care (SoC)

NO INTERVENTION

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.

Interventions

FS VH S/D 4 s-apr BIOLOGICAL

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.

Also known as: ARTISS

FS VH S/D 4 s-apr

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (6)

Unknown Facility

Beverly Hills, California, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Evans, Georgia, United States

Location

Unknown Facility

Hewlett, New York, United States

Location

Unknown Facility

Chattanooga, Tennessee, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Related Publications (1)

• 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.

  PMID: 23563904 DERIVED

MeSH Terms

Interventions

Low Density Lipoprotein Receptor-Related Protein-1

Intervention Hierarchy (Ancestors)

LDL-Receptor Related Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, LDL; Receptors, Lipoprotein; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Edith Hantak, DVM, Dir, Global Therapeutic Area, BioSurgery
• Organization: Baxter Innovations, GmbH

edith_hantak@baxter.com

Study Officials

• Steve Z Abrams, MD

  Baxter Healthcare Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2009
• First Posted: October 21, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: February 1, 2010
• Last Updated: October 8, 2012
• Results First Posted: August 27, 2012

Record last verified: 2012-10

Locations

US (6)