Efficacy and Safety of FS VH S/D 4 S-apr for Flap Adherence in Rhytidectomy

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Baxter Healthcare Corporation

ClinicalTrials.gov Identifier:

NCT00999141

First received: October 20, 2009

Last updated: October 4, 2012

Last verified: October 2012

History of Changes

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 (Subject); Primary Purpose: Treatment
Conditions:	Face-lift Facial Rhytidectomy
Intervention:	Biological: FS VH S/D 4 s-apr

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 7 clinical sites in the United States, beginning September 2009 and completing in December 2009

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
79 participants were enrolled and screened. 2 were screen failures and 2 requested withdrawal. Therefore, 75 of the 79 enrolled were randomized.

Reporting Groups

	Description
Facelift Participants	One side of face will be treated with the investigational product (FS VH S/D 4 s-apr) as an adjuvant to the standard of care (SoC), and the other side of the face will receive SoC alone. Please note: Each subject will participate in both arms (investigational product and SoC) simultaneously, and will serve as his/her own control.

Participant Flow: Overall Study

	Facelift Participants
STARTED	75 ^[1]
COMPLETED	75
NOT COMPLETED	0

[1]	Randomized and treated

Baseline Characteristics

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Reporting Groups

	Description
Facelift Participants	One side of face will be treated with the investigational product (FS VH S/D 4 s-apr) as an adjuvant to the standard of care (SoC), and the other side of the face will receive SoC alone. Please note: Each subject will participate in both arms (investigational product and SoC) simultaneously, and will serve as his/her own control.

Baseline Measures

	Facelift Participants
Number of Participants [units: participants]	75
Age [units: years] Mean ± Standard Deviation	54.4 ± 7.4
Gender [units: participants]
Female	71
Male	4
Region of Enrollment [units: participants]
United States	75

Outcome Measures

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1. Primary:

Total Volume of Drainage on Each Side of the Face [ Time Frame: 24 hours (± 4h) after surgery ]

Show Outcome Measure 1

2. Primary:

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 ]

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3. Secondary:

Participants' First Occurrence of Hematoma or Seroma by Study Day [ Time Frame: Day 0 (day of surgery) through postoperative day 14 ]

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4. Secondary:

Participants With Hematoma/Seroma by Study Day [ Time Frame: Day 0 (day of surgery) through postoperative day 14 ]

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5. Secondary:

Number of Participants With Hematoma/Seroma Anytime During the Study [ Time Frame: Day 0 (day of surgery) through postoperative Day 14 ]

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6. Secondary:

Investigators’ Visual Comparisons of Edema Between the 2 Sides of Face at Day 1 [ Time Frame: Through postoperative Day 1 ]

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7. Secondary:

Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 3 [ Time Frame: Through postoperative Day 3 ]

Show Outcome Measure 7

8. Secondary:

Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 7 [ Time Frame: Through postoperative Day 7 ]

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9. Secondary:

Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 14 [ Time Frame: Through postoperative Day 14 ]

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10. Secondary:

Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14 [ Time Frame: Day 0 (preoperative) through postoperative Day 14 ]

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11. Secondary:

Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14 [ Time Frame: Through postoperative Day 14 ]

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12. Secondary:

Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 1 [ Time Frame: Through postoperative Day 1 ]

Show Outcome Measure 12

13. Secondary:

Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 3 [ Time Frame: Through postoperative Day 3 ]

Show Outcome Measure 13

14. Secondary:

Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 7 [ Time Frame: Through postoperative Day 7 ]

Show Outcome Measure 14

15. Secondary:

Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 14 [ Time Frame: Through postoperative Day 14 ]

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16. Secondary:

Reasons for Participants’ Preferences for Side of Face [ Time Frame: Through postoperative Day 14 ]

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17. Other Pre-specified:

Participants' Assessment of Difference in Numbness Between Two Sides of Face [ Time Frame: Through postoperative Day 14 ]

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18. Other Pre-specified:

Investigator Preference for Side of Face [ Time Frame: Through postoperative Day 14 ]

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19. Other Pre-specified:

Investigators' Satisfaction With Quality of Flap Adherence [ Time Frame: Through postoperative Day 14 ]

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20. Other Pre-specified:

Investigators' Satisfaction With Rate of Healing [ Time Frame: Through postoperative Day 14 ]

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21. Other Pre-specified:

Investigators' Satisfaction With Treatment [ Time Frame: Through postoperative Day 14 ]

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22. Other Pre-specified:

Investigators’ Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr [ Time Frame: Through postoperative Day 14 ]

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23. Other Pre-specified:

Total Aspiration Volumes From Hematomas and Seromas [ Time Frame: Through postoperative Day 14 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Baxter’s agreements with PIs may vary per requirements of the individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication or 1 year after study completion. Baxter requires a review of results communications (e.g., for confidential information) ≥90 days prior to submission or communication. Baxter may request an additional delay of ≤60 days (e.g., for intellectual property protection)

Limitations and Caveats

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
No text entered.

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

Responsible Party:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00999141 History of Changes
Other Study ID Numbers:	550901
Study First Received:	October 20, 2009
Results First Received:	October 6, 2011
Last Updated:	October 4, 2012
Health Authority:	United States: Food and Drug Administration

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