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)

Baxter Healthcare Corporation0 sites75 target enrollmentSeptember 2009

ConditionsFace-lift Facial Rhytidectomy

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Face-lift
Sponsor: Baxter Healthcare Corporation
Enrollment: 75
Primary Endpoint: Total Volume of Drainage on Each Side of the Face
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

February 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Baxter Healthcare Corporation

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Total Volume of Drainage on Each Side of the Face

Time Frame: 24 hours (± 4h) after surgery

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).

Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr)

Time Frame: Day 0 (day of surgery) through postoperative Day 14

Secondary Outcomes

Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 14(Through postoperative Day 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)
Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 7(Through postoperative Day 7)
Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14(Day 0 (preoperative) through postoperative Day 14)
Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14(Through postoperative Day 14)
Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 1(Through postoperative Day 1)
Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 3(Through postoperative Day 3)
Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 7(Through postoperative Day 7)
Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 14(Through postoperative Day 14)
Reasons for Participants' Preferences for Side of Face(Through postoperative Day 14)