Phase 3 N=75 Randomized Single-blind Treatment

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

Face-lift · Facial Rhytidectomy

Bottom Line

View on ClinicalTrials.gov: NCT00999141 ↗

Enrolled (actual)

Serious AEs

0.9%

Results posted

Aug 2012

Primary outcome: Primary: Total Volume of Drainage on Each Side of the Face — 20.0; 8.0 mL — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: FS VH S/D 4 s-apr (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Baxter Healthcare Corporation
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Volume of Drainage on Each Side of the Face	20.0; 8.0	<0.0001 sig
PRIMARY Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr)	0; 0; 0; 1; 0; 0	—
SECONDARY Participants' First Occurrence of Hematoma or Seroma by Study Day	0; 0; 1; 0; 1; 2	—
SECONDARY Participants With Hematoma/Seroma by Study Day	0; 1; 3; 1; 2; 1	—
SECONDARY Number of Participants With Hematoma/Seroma Anytime During the Study	2; 5; 3; 65	0.257
SECONDARY Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 1	40; 12; 23	<0.001 sig
SECONDARY Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 3	41; 12; 22	<0.001 sig
SECONDARY Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 7	41; 15; 17	0.001 sig
SECONDARY Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 14	27; 13; 34	0.027 sig
SECONDARY Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14	0.54; 0.60; 0.44; 0.51; 0.24; 0.32	—
SECONDARY Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14	47; 16; 12; 40; 23; 12	—
SECONDARY Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 1	0.63; 0.21	—
SECONDARY Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 3	0.53; 0.31	—
SECONDARY Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 7	0.59; 0.24	—
SECONDARY Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 14	0.57; 0.20	—
SECONDARY Reasons for Participants' Preferences for Side of Face	19; 5; 15; 4; 19; 7	—

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

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Data sourced from ClinicalTrials.gov (NCT00999141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.