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

NCT ID: NCT00999141

Last Updated: 2012-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

FS VH S/D 4 s-apr

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

ARTISS

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steve Z Abrams, MD

Role: STUDY_DIRECTOR

Baxter Healthcare Corporation

Locations

Beverly Hills, California, United States

Atlanta, Georgia, United States

Evans, Georgia, United States

Hewlett, New York, United States

Chattanooga, Tennessee, United States

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23563904 (View on PubMed)

Other Identifiers

550901

Identifier Type: -

Identifier Source: org_study_id