Clinical trial NCT00708071: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Facial Rhytidectomy (Face-lift)
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2008-07-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Visual Comparison of Ecchymosis at Postoperative Day 3
timeFrame: Through Postoperative Day 3
measure: Incidence of Adverse Events (AEs) Related to Study Product (FS VH S/D 4) Throughout the Study Period
timeFrame: Through Postoperative Day 14 (± 1)
Secondary outcomes:
measure: Visual Comparison of Ecchymosis at Day 1
timeFrame: Through Postoperative Day 1
measure: Visual Comparison of Ecchymosis at Day 5
timeFrame: Through Postoperative Day 5
measure: Visual Comparison of Ecchymosis at Day 7
timeFrame: Through Postoperative Day 7
measure: Visual Comparison of Ecchymosis at Day 10
timeFrame: Through Postoperative Day 10
measure: Visual Comparison of Ecchymosis at Day 14
timeFrame: Through Postoperative Day 14
measure: 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
timeFrame: Through Postoperative Day 1
measure: 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
timeFrame: Through Postoperative Day 3
measure: 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
timeFrame: Through Postoperative Day 5
measure: 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
timeFrame: Through Postoperative Day 7
measure: 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
timeFrame: Through Postoperative Day 10
measure: 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
timeFrame: Through Postoperative Day 14
measure: 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
timeFrame: Postoperative Day 3
measure: Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 1
timeFrame: Through Postoperative Day 1
measure: Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 3
timeFrame: Through Postoperative Day 3
measure: Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 5
timeFrame: Through Postoperative Day 5
measure: Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 7
timeFrame: Through Postoperative Day 7
measure: Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 10
timeFrame: Through Postoperative Day 10
measure: Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 14
timeFrame: Through Postoperative Day 14
measure: Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 1
timeFrame: Through Postoperative Day 1
measure: Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 3
timeFrame: Through Postoperative Day 3
measure: Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 5
timeFrame: Through Postoperative Day 5
measure: Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 7
timeFrame: Through Postoperative Day 7
measure: Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 10
timeFrame: Through Postoperative Day 10
measure: Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 14
timeFrame: Through Postoperative Day 14
measure: Resolution of Ecchymosis as Assessed by Investigators
timeFrame: Postoperative Days 1, 3, 5, 7, 10, and 14
measure: Resolution of Edema as Assessed by Investigators.
timeFrame: Postoperative Days 1, 3, 5, 7, 10, and 14
measure: Total Volume of Drainage on Each Side of the Face
timeFrame: 24 hours postoperative
measure: Participants With Hematoma/Seroma
timeFrame: Days 0, 1, 3, 5, 7,10, and 14
measure: Participants With Hematoma/Seroma During the Study
timeFrame: Through Postoperative Day 14 (± 1)
measure: Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14
timeFrame: Postoperative Days 3, 7, 10, and 14
measure: Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4)
timeFrame: Days 1, 3, 5, 7,10, and 14
measure: Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4)
timeFrame: Days 1, 3, 5, 7,10, and 14
measure: Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4)
timeFrame: Postoperative Days 1, 3, 5, 7, 10, and 14
Other outcomes:
Locations:
city: Beverly Hills
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Atlanta
country: United States
state: Georgia
city: Evans
country: United States
state: Georgia
city: Hewlett
country: United States
state: New York
city: Chattanooga
country: United States
state: Tennessee
Study officials:
affiliation: Baxter Healthcare Corporation
name: Steve Z Abrams, MD
role: STUDY_DIRECTOR
References:
citation: Hester TR Jr, Gerut ZE, Shire JR, Nguyen DB, Chen AH, Diamond J, Desmond JC, Silvati-Fidell L, Abrams SZ. Exploratory, randomized, controlled, phase 2 study to evaluate the safety and efficacy of adjuvant fibrin sealant VH S/D 4 S-Apr (ARTISS) in patients undergoing rhytidectomy. Aesthet Surg J. 2013 Mar;33(3):323-33. doi: 10.1177/1090820X13477860.