An Exploratory Phase 2 Clinical Study to Evaluate Efficacy and Safety of the Adjuvant Use of Fibrin Sealant With 4 IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4) in Subjects Undergoing Rhytidectomy

Baxter Healthcare Corporation0 sites45 target enrollmentJune 2008

ConditionsFacial Rhytidectomy (Face-lift)

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Facial Rhytidectomy (Face-lift)
Sponsor: Baxter Healthcare Corporation
Enrollment: 45
Primary Endpoint: Visual Comparison of Ecchymosis at Postoperative Day 3
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The primary objective of this study is to evaluate the efficacy and safety of fibrin sealant with 4 IU/mL thrombin, vapor heated, solvent detergent treated (FS VH S/D 4) when used to reduce early postoperative bruising in participants undergoing a rhytidectomy (face-lift).

Registry

clinicaltrials.gov

Start Date

June 2008

End Date

September 2008

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

•Subjects planned for facial rhytidectomy
•Subjects who read, understand and sign the written informed consent
•Healthy female or male subjects as determined by the investigator using standard pre-operative assessments to include laboratory tests and ECG
•Subjects 18-75 years old, inclusively
•Subjects who are able and willing to comply with the protocol requirements
•Female subjects of childbearing potential with a negative urine or serum pregnancy test within 72 hours of surgery

Exclusion Criteria

•Pregnant or lactating women
•Subjects who have undergone previous face-lift surgery
•Subjects undergoing abbreviated face-lift procedures such as deep plane procedures, minimal undermining procedures, thread lifts, and minimal access cranial suspension
•Subjects indicated for concurrent facial surgeries during the operation (e.g. forehead plasty, blepharoplasty, rhinoplasty, buccal fat removal, any filler injections including fat injections, lip augmentation, skin resurfacing procedures etc.)
•Subjects indicated for additional procedures during the same operation (e.g., liposuction, mastoplasty etc.)
•Subjects who had prior silicone injections to their face (Botox and/or Restylane are allowed)
•Subjects considered by the investigator to be smokers
•Subjects with ecchymosis and/or edema on the face on day 0, prior to surgery
•Subjects with known (documented) bleeding or coagulation disorders
•Subjects currently being treated with anti-coagulants

Outcomes

Primary Outcomes

Visual Comparison of Ecchymosis at Postoperative Day 3

Time Frame: Through Postoperative Day 3

Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.

Incidence of Adverse Events (AEs) Related to Study Product (FS VH S/D 4) Throughout the Study Period

Time Frame: Through Postoperative Day 14 (± 1)

Secondary Outcomes

Visual Comparison of Ecchymosis at Day 1(Through Postoperative Day 1)
Visual Comparison of Ecchymosis at Day 5(Through Postoperative Day 5)
Visual Comparison of Ecchymosis at Day 7(Through Postoperative Day 7)
Visual Comparison of Ecchymosis at Day 10(Through Postoperative Day 10)
Visual Comparison of Ecchymosis at Day 14(Through Postoperative Day 14)
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 1(Through Postoperative Day 1)
Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14(Postoperative Days 3, 7, 10, and 14)
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 3(Through Postoperative Day 3)
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 5(Through Postoperative Day 5)
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 7(Through Postoperative Day 7)
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 10(Through Postoperative Day 10)
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 14(Through Postoperative Day 14)
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by a Blinded On-site Evaluator-Day 3(Postoperative Day 3)
Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 1(Through Postoperative Day 1)
Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 3(Through Postoperative Day 3)
Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 5(Through Postoperative Day 5)
Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 7(Through Postoperative Day 7)
Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 10(Through Postoperative Day 10)
Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 14(Through Postoperative Day 14)
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 1(Through Postoperative Day 1)
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 3(Through Postoperative Day 3)
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 5(Through Postoperative Day 5)
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 7(Through Postoperative Day 7)
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 10(Through Postoperative Day 10)
Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 14(Through Postoperative Day 14)
Resolution of Ecchymosis as Assessed by Investigators(Postoperative Days 1, 3, 5, 7, 10, and 14)
Resolution of Edema as Assessed by Investigators.(Postoperative Days 1, 3, 5, 7, 10, and 14)
Total Volume of Drainage on Each Side of the Face(24 hours postoperative)
Participants With Hematoma/Seroma(Days 0, 1, 3, 5, 7,10, and 14)
Participants With Hematoma/Seroma During the Study(Through Postoperative Day 14 (± 1))
Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4)(Days 1, 3, 5, 7,10, and 14)
Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4)(Days 1, 3, 5, 7,10, and 14)
Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4)(Postoperative Days 1, 3, 5, 7, 10, and 14)