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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00708071
First received: June 30, 2008
Last updated: October 19, 2012
Last verified: October 2012
Results First Received: October 6, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Facial Rhytidectomy (Face-lift)
Intervention: Biological: Fibrin Sealant with 4 IU/ml Thrombin, Vapor-Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled at 6 clinical sites in the United States, beginning June 2008 and completing in September 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
56 participants were enrolled and screened. 2 were screen failures. 9 were withdrawn prior to randomization (1 due to untoward medical occurrence, 2 due to study site over enrollment, 2 requested withdrawal, 2 had scheduling conflicts, 1 had surgery delayed, 1 missed deadline for enrollment. Therefore, 45 of the 56 enrolled were randomized.

Reporting Groups
  Description
Facelift Participants One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.

Participant Flow:   Overall Study
    Facelift Participants  
STARTED     45 [1]
COMPLETED     45  
NOT COMPLETED     0  
[1] Randomized and treated



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Facelift Participants One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.

Baseline Measures
    Facelift Participants  
Number of Participants  
[units: participants]
  45  
Age  
[units: years]
Mean ± Standard Deviation
  55.1  ± 6.9  
Gender  
[units: participants]
 
Female     42  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     45  



  Outcome Measures
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1.  Primary:   Visual Comparison of Ecchymosis at Postoperative Day 3   [ Time Frame: Through Postoperative Day 3 ]

2.  Primary:   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) ]

3.  Secondary:   Visual Comparison of Ecchymosis at Day 1   [ Time Frame: Through Postoperative Day 1 ]

4.  Secondary:   Visual Comparison of Ecchymosis at Day 5   [ Time Frame: Through Postoperative Day 5 ]

5.  Secondary:   Visual Comparison of Ecchymosis at Day 7   [ Time Frame: Through Postoperative Day 7 ]

6.  Secondary:   Visual Comparison of Ecchymosis at Day 10   [ Time Frame: Through Postoperative Day 10 ]

7.  Secondary:   Visual Comparison of Ecchymosis at Day 14   [ Time Frame: Through Postoperative Day 14 ]

8.  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   [ Time Frame: Through Postoperative Day 1 ]

9.  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   [ Time Frame: Through Postoperative Day 3 ]

10.  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   [ Time Frame: Through Postoperative Day 5 ]

11.  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   [ Time Frame: Through Postoperative Day 7 ]

12.  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   [ Time Frame: Through Postoperative Day 10 ]

13.  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   [ Time Frame: Through Postoperative Day 14 ]

14.  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   [ Time Frame: Postoperative Day 3 ]

15.  Secondary:   Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 1   [ Time Frame: Through Postoperative Day 1 ]

16.  Secondary:   Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 3   [ Time Frame: Through Postoperative Day 3 ]

17.  Secondary:   Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 5   [ Time Frame: Through Postoperative Day 5 ]

18.  Secondary:   Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 7   [ Time Frame: Through Postoperative Day 7 ]

19.  Secondary:   Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 10   [ Time Frame: Through Postoperative Day 10 ]

20.  Secondary:   Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 14   [ Time Frame: Through Postoperative Day 14 ]

21.  Secondary:   Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 1   [ Time Frame: Through Postoperative Day 1 ]

22.  Secondary:   Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 3   [ Time Frame: Through Postoperative Day 3 ]

23.  Secondary:   Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 5   [ Time Frame: Through Postoperative Day 5 ]

24.  Secondary:   Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 7   [ Time Frame: Through Postoperative Day 7 ]

25.  Secondary:   Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 10   [ Time Frame: Through Postoperative Day 10 ]

26.  Secondary:   Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 14   [ Time Frame: Through Postoperative Day 14 ]

27.  Secondary:   Resolution of Ecchymosis as Assessed by Investigators   [ Time Frame: Postoperative Days 1, 3, 5, 7, 10, and 14 ]

28.  Secondary:   Resolution of Edema as Assessed by Investigators.   [ Time Frame: Postoperative Days 1, 3, 5, 7, 10, and 14 ]

29.  Secondary:   Total Volume of Drainage on Each Side of the Face   [ Time Frame: 24 hours postoperative ]

30.  Secondary:   Participants With Hematoma/Seroma   [ Time Frame: Days 0, 1, 3, 5, 7,10, and 14 ]

31.  Secondary:   Participants With Hematoma/Seroma During the Study   [ Time Frame: Through Postoperative Day 14 (± 1) ]

32.  Secondary:   Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14   [ Time Frame: Postoperative Days 3, 7, 10, and 14 ]

33.  Secondary:   Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4)   [ Time Frame: Days 1, 3, 5, 7,10, and 14 ]

34.  Secondary:   Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4)   [ Time Frame: Days 1, 3, 5, 7,10, and 14 ]

35.  Secondary:   Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4)   [ Time Frame: Postoperative Days 1, 3, 5, 7, 10, and 14 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Edith Hantak, DVM, Dir, Global Therapeutic Area, BioSurgery
Organization: Baxter Innovations, GmbH
e-mail: edith_hantak@baxter.com


No publications provided by Baxter Healthcare Corporation

Publications automatically indexed to this study:

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00708071     History of Changes
Other Study ID Numbers: 550703
Study First Received: June 30, 2008
Results First Received: October 6, 2011
Last Updated: October 19, 2012
Health Authority: United States: Food and Drug Administration