Phase 2 N=45 Randomized Single-blind Treatment

Efficacy and Safety Study of Fibrin Sealant With 4 IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated (FS VH S/D 4) in Face-Lift Procedures

Facial Rhytidectomy (Face-lift)

Bottom Line

View on ClinicalTrials.gov: NCT00708071 ↗

Enrolled (actual)

Serious AEs

0.7%

Results posted

Aug 2012

Primary outcome: Primary: Visual Comparison of Ecchymosis at Postoperative Day 3 — 5; 12; 11; 0 participants — p=0.143

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Fibrin Sealant with 4 IU/ml Thrombin, Vapor-Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4) (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Baxter Healthcare Corporation
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Visual Comparison of Ecchymosis at Postoperative Day 3	5; 12; 11; 0	0.143
PRIMARY Incidence of Adverse Events (AEs) Related to Study Product (FS VH S/D 4) Throughout the Study Period	—	—
SECONDARY Visual Comparison of Ecchymosis at Day 1	2; 11; 16; 0	—
SECONDARY Visual Comparison of Ecchymosis at Day 5	5; 8; 14; 0	—
SECONDARY Visual Comparison of Ecchymosis at Day 7	9; 8; 14; 0	—
SECONDARY Visual Comparison of Ecchymosis at Day 10	7; 7; 14; 0	—
SECONDARY Visual Comparison of Ecchymosis at Day 14	5; 6; 14; 1	—
SECONDARY 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	0.0	0.645
SECONDARY 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	-0.2	0.103
SECONDARY 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	0.0	0.833
SECONDARY 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	0.0	0.501
SECONDARY 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	0.0	0.247
SECONDARY 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	0.0	0.715
SECONDARY 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	0.00	—
SECONDARY Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 1	0.00	0.754
SECONDARY Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 3	0.0	0.388
SECONDARY Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 5	0.0	0.234
SECONDARY Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 7	0.0	0.688
SECONDARY Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 10	0.0	0.625
SECONDARY Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 14	0.0	0.688
SECONDARY Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 1	0.0	1.000
SECONDARY Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 3	0.0	0.521
SECONDARY Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 5	0.0	0.324
SECONDARY Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 7	0.0	0.661
SECONDARY Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 10	0.0	1.000
SECONDARY Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 14	0.0	0.699
SECONDARY Resolution of Ecchymosis as Assessed by Investigators	0; 0; 2; 31; 0; 0	—
SECONDARY Resolution of Edema as Assessed by Investigators.	3; 0; 0; 29; 0; 0	—
SECONDARY Total Volume of Drainage on Each Side of the Face	16; 5	0.0010 sig
SECONDARY Participants With Hematoma/Seroma	2; 0; 1; 0; 2; 0	—
SECONDARY Participants With Hematoma/Seroma During the Study	0; 6; 0; 27	0.014 sig
SECONDARY Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14	7; 7; 5; 6; 5; 5	—
SECONDARY Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4)	0; 0; 0; 0; 0; 0	—
SECONDARY Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4)	0; 0; 0; 0; 0; 0	—
SECONDARY Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4)	5; 12; 16; 1; 20; 12	—

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).

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
Subjects treated with Aspirin in the last 7 days or use of other Non-steroidal anti-inflammatory drug (NSAIDs) within the last 7 days prior to surgery
Subjects with vascular disorders, cardiovascular disease, and/or uncontrolled hypertension
Subjects with diabetes mellitus
Subjects with a history of Bell´s palsy
Subjects with connective tissue disorders
Subjects with documented history of pathologically or pharmacologically induced immune deficiency
Subjects receiving systemic corticosteroid treatment for a chronic condition within 2 to 30 days prior to the surgery
Subjects with a known sensitivity to fibrin sealants
Subjects with a known psychiatric disorder (e.g., depression, obsessive compulsive disorder, anxiety, eating disorders, etc)
Subjects who have participated in another clinical study within 30 days prior to this study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00708071). 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.