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

Baxter

Status and phase: Completed; Phase 3

Conditions: Facial Rhytidectomy; Face-lift

Treatments: Biological: FS VH S/D 4 s-apr

Study type: Interventional

Funder types: Industry

Identifiers

NCT00999141

550901

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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75 participants in 2 patient groups

FS VH S/D 4 s-apr

Experimental group

Description:

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.

Treatment:

Biological: FS VH S/D 4 s-apr

Standard of Care (SoC)

No Intervention group

Description:

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.