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The purpose of the study is to compare the safety and efficacy of FS VH S/D 4 s-apr versus standard of care in adhering tissue and improving wound healing in subjects undergoing facelift.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FS VH S/D 4 s-apr | Experimental | 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. Please note: Each subject will participate in both arms (investigational product and standard of care) simultaneously, and will serve as his/her own control. |
|
| Standard of Care (SoC) | No Intervention | Other side of face will receive standard of care. Please note: Each subject will participate in both arms (investigational product and standard of care) simultaneously, and will serve as his/her own control. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FS VH S/D 4 s-apr | Biological | FS VH S/D 4 s-apr will be applied (using spray device provided by Sponsor) to the subcutaneous plane (intraoperative, topical administration) in both the neck and the face area. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Volume of Drainage on Each Side of the Face | Total drainage volume collected from each side of the face. One side of face is treated with FS VH S/D 4 s-apr (FS); the other side is treated using standard of care (SoC). | 24 hours (± 4h) after surgery |
| Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr) | Day 0 (day of surgery) through postoperative Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Participants' First Occurrence of Hematoma or Seroma by Study Day | Investigators assessed each side of the face for the presence of hematomas and/or seromas | Day 0 (day of surgery) through postoperative day 14 |
| Participants With Hematoma/Seroma by Study Day |
| Measure | Description | Time Frame |
|---|---|---|
| Participants' Assessment of Difference in Numbness Between Two Sides of Face | During each postoperative visit (Day 1, 3, 7, and 14), participants were asked: How would you rate your numbness on each side of your face on a scale of 0-10, with 10 being the worst numbness possible? Difference in scores on a scale = (SoC score) - (FS VH S/D 4 s-apr score) The planned and approved Statistical Analysis Plan (SAP) called for a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Z Abrams, MD | Baxter Healthcare Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beverly Hills | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23563904 | Derived | Hester TR Jr, Shire JR, Nguyen DB, Gerut ZE, Chen AH, Diamond J, Desmond JC, Silvati-Fidell L, Abrams SZ, Rohrich RJ. Randomized, controlled, phase 3 study to evaluate the safety and efficacy of fibrin sealant VH S/D 4 s-apr (Artiss) to improve tissue adherence in subjects undergoing rhytidectomy. Aesthet Surg J. 2013 May;33(4):487-96. doi: 10.1177/1090820X13479969. Epub 2013 Apr 5. |
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79 participants were enrolled and screened. 2 were screen failures and 2 requested withdrawal. Therefore, 75 of the 79 enrolled were randomized.
Patients were enrolled at 7 clinical sites in the United States, beginning September 2009 and completing in December 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Volume of Drainage on Each Side of the Face | Total drainage volume collected from each side of the face. One side of face is treated with FS VH S/D 4 s-apr (FS); the other side is treated using standard of care (SoC). | Full Analysis Data Set = All randomized and treated participants | Posted | Median | Full Range | mL | 24 hours (± 4h) after surgery |
|
|
Day 0 (day of surgery) through postoperative Day 14
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Localized to SoC Side of Face | AE was localized to the side of the face which was treated with standard of care (SoC). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound abscess | Infections and infestations | MedDRA (Unspecified) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA (Unspecified) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edith Hantak, DVM, Dir, Global Therapeutic Area, BioSurgery | Baxter Innovations, GmbH | edith_hantak@baxter.com |
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| ID | Term |
|---|---|
| D026503 | Low Density Lipoprotein Receptor-Related Protein-1 |
| ID | Term |
|---|---|
| D026502 | LDL-Receptor Related Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011973 | Receptors, LDL |
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|
Investigators assessed each side of the face for the presence of hematoma and/or seroma |
| Day 0 (day of surgery) through postoperative day 14 |
| Number of Participants With Hematoma/Seroma Anytime During the Study | Day 0 (day of surgery) through postoperative Day 14 |
| Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 1 | Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema | Through postoperative Day 1 |
| Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 3 | Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema | Through postoperative Day 3 |
| Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 7 | Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema | Through postoperative Day 7 |
| Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 14 | Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema | Through postoperative Day 14 |
| Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14 | Skin sensitivity was measured using Semmes-Weinstein Monofilament set to detect neurological damage. Filament sizes are noted by handle numbers of measuring tools ([handle number = log10(10*force in milligrams applied to skin)], range = 1.65 to 6.65). Detection of filament with smaller handle number = greater skin sensitivity. Smaller change in filament size detection from pre-op to post-op = less impact to recovery of sensation. Smallest filament felt for each side of face was noted. Change in skin sensitivity computed as (Handle Number Postop Day 3, 7, or 14) - (Handle Number Preop Day 0). | Day 0 (preoperative) through postoperative Day 14 |
| Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14 | Participants responded to the following question during the side of face preference assessment: "Which side of the face do you prefer? Left side, right side, or no preference?" | Through postoperative Day 14 |
| Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 1 | Participants responded to the following question during the side of face preference assessment: "Which side of the face do you prefer? Left side, right side, or no preference?" | Through postoperative Day 1 |
| Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 3 | Participants responded to the following question during the side of face preference assessment: "Which side of the face do you prefer? Left side, right side, or no preference?" | Through postoperative Day 3 |
| Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 7 | Participants responded to the following question during the side of face preference assessment: "Which side of the face do you prefer? Left side, right side, or no preference?" | Through postoperative Day 7 |
| Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 14 | Participants responded to the following question during the side of face preference assessment: "Which side of the face do you prefer? Left side, right side, or no preference?" | Through postoperative Day 14 |
| Reasons for Participants' Preferences for Side of Face | Participants responded to the following questions during the side of face preference assessment:
| Through postoperative Day 14 |
| Through postoperative Day 14 |
| Investigator Preference for Side of Face | Investigator reported outcomes data was collected for overall preference for 1 side of face | Through postoperative Day 14 |
| Investigators' Satisfaction With Quality of Flap Adherence | During postoperative visits investigators recorded their satisfaction with the quality of flap adherence for each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face) | Through postoperative Day 14 |
| Investigators' Satisfaction With Rate of Healing | During postoperative visits investigators recorded their satisfaction with the rate of healing of each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face) | Through postoperative Day 14 |
| Investigators' Satisfaction With Treatment | During postoperative visits investigators recorded their satisfaction with treatment on each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face) | Through postoperative Day 14 |
| Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr | Through postoperative Day 14 |
| Total Aspiration Volumes From Hematomas and Seromas | Through postoperative Day 14 |
| Atlanta |
| Georgia |
| United States |
| Evans | Georgia | United States |
| Hewlett | New York | United States |
| Chattanooga | Tennessee | United States |
| Dallas | Texas | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Secondary | Participants' First Occurrence of Hematoma or Seroma by Study Day | Investigators assessed each side of the face for the presence of hematomas and/or seromas | Full Analysis Data Set = All randomized and treated participants | Posted | Number | participants | Day 0 (day of surgery) through postoperative day 14 |
|
|
|
| Secondary | Participants With Hematoma/Seroma by Study Day | Investigators assessed each side of the face for the presence of hematoma and/or seroma | Full Analysis Data Set = All randomized and treated participants | Posted | Number | participants | Day 0 (day of surgery) through postoperative day 14 |
|
|
|
| Secondary | Number of Participants With Hematoma/Seroma Anytime During the Study | Full Analysis Data Set = All randomized and treated participants | Posted | Number | participants | Day 0 (day of surgery) through postoperative Day 14 |
|
|
|
|
| Secondary | Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 1 | Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema | Full Analysis Data Set = All randomized and treated participants | Posted | Number | participants | Through postoperative Day 1 |
|
|
|
|
| Secondary | Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 3 | Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema | Full Analysis Data Set = All randomized and treated participants | Posted | Number | participants | Through postoperative Day 3 |
|
|
|
|
| Secondary | Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 7 | Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema | Full Analysis Data Set = All randomized and treated participants | Posted | Number | participants | Through postoperative Day 7 |
|
|
|
|
| Secondary | Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 14 | Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema | Full Analysis Data Set = All randomized and treated participants | Posted | Number | participants | Through postoperative Day 14 |
|
|
|
|
| Secondary | Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14 | Skin sensitivity was measured using Semmes-Weinstein Monofilament set to detect neurological damage. Filament sizes are noted by handle numbers of measuring tools ([handle number = log10(10*force in milligrams applied to skin)], range = 1.65 to 6.65). Detection of filament with smaller handle number = greater skin sensitivity. Smaller change in filament size detection from pre-op to post-op = less impact to recovery of sensation. Smallest filament felt for each side of face was noted. Change in skin sensitivity computed as (Handle Number Postop Day 3, 7, or 14) - (Handle Number Preop Day 0). | Full Analysis Data Set = All randomized and treated participants | Posted | Mean | 95% Confidence Interval | Handle number(s) | Day 0 (preoperative) through postoperative Day 14 |
|
|
|
| Secondary | Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14 | Participants responded to the following question during the side of face preference assessment: "Which side of the face do you prefer? Left side, right side, or no preference?" | Full Analysis Data Set = All randomized and treated participants | Posted | Number | participants | Through postoperative Day 14 |
|
|
|
| Secondary | Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 1 | Participants responded to the following question during the side of face preference assessment: "Which side of the face do you prefer? Left side, right side, or no preference?" | Full Analysis Data Set = All randomized and treated participants | Posted | Number | Proportion of Participants | Through postoperative Day 1 |
|
|
|
|
| Secondary | Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 3 | Participants responded to the following question during the side of face preference assessment: "Which side of the face do you prefer? Left side, right side, or no preference?" | Full Analysis Data Set = All randomized and treated participants | Posted | Number | Proportion of Participants | Through postoperative Day 3 |
|
|
|
|
| Secondary | Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 7 | Participants responded to the following question during the side of face preference assessment: "Which side of the face do you prefer? Left side, right side, or no preference?" | Full Analysis Data Set = All randomized and treated participants | Posted | Number | Proportion of Participants | Through postoperative Day 7 |
|
|
|
|
| Secondary | Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 14 | Participants responded to the following question during the side of face preference assessment: "Which side of the face do you prefer? Left side, right side, or no preference?" | Full Analysis Data Set = All randomized and treated participants | Posted | Number | Proportion of Participants | Through postoperative Day 14 |
|
|
|
|
| Secondary | Reasons for Participants' Preferences for Side of Face | Participants responded to the following questions during the side of face preference assessment:
| Full Analysis Data Set = All randomized and treated participants | Posted | Number | Participants | Through postoperative Day 14 |
|
|
|
| Other Pre-specified | Participants' Assessment of Difference in Numbness Between Two Sides of Face | During each postoperative visit (Day 1, 3, 7, and 14), participants were asked: How would you rate your numbness on each side of your face on a scale of 0-10, with 10 being the worst numbness possible? Difference in scores on a scale = (SoC score) - (FS VH S/D 4 s-apr score) The planned and approved Statistical Analysis Plan (SAP) called for a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. | Full Analysis Data Set = All randomized and treated participants | Posted | Mean | Standard Deviation | Scores on a scale | Through postoperative Day 14 |
|
|
|
| Other Pre-specified | Investigator Preference for Side of Face | Investigator reported outcomes data was collected for overall preference for 1 side of face | Full Analysis Data Set = All randomized and treated participants | Posted | Number | participants | Through postoperative Day 14 |
|
|
|
| Other Pre-specified | Investigators' Satisfaction With Quality of Flap Adherence | During postoperative visits investigators recorded their satisfaction with the quality of flap adherence for each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face) | Full Analysis Data Set = All randomized and treated participants | Posted | Number | participants | Through postoperative Day 14 |
|
|
|
| Other Pre-specified | Investigators' Satisfaction With Rate of Healing | During postoperative visits investigators recorded their satisfaction with the rate of healing of each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face) | Full Analysis Data Set = All randomized and treated participants | Posted | Number | participants | Through postoperative Day 14 |
|
|
|
| Other Pre-specified | Investigators' Satisfaction With Treatment | During postoperative visits investigators recorded their satisfaction with treatment on each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face) | Full Analysis Data Set = All randomized and treated participants | Posted | Number | participants | Through postoperative Day 14 |
|
|
|
| Other Pre-specified | Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr | Full Analysis Data Set = All randomized and treated participants | Posted | Number | participants | Through postoperative Day 14 |
|
|
|
| Other Pre-specified | Total Aspiration Volumes From Hematomas and Seromas | Full Analysis Data Set = All randomized and treated participants | Posted | Median | Full Range | mL | Through postoperative Day 14 |
|
|
|
| Primary | Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr) | Safety Analysis Set | Posted | Number | Events | Day 0 (day of surgery) through postoperative Day 14 |
|
|
|
| 0 |
| 75 |
| 8 |
| 75 |
| EG001 | Localized to FS VH S/D 4 S-apr Side of Face | AE was localized to the side of the face which was treated with FS VH S/D 4 s-apr | 1 | 75 | 5 | 75 |
| EG002 | Non-localized AEs | AE affected a site other than either side of the face (ie, non-localized AE) | 1 | 75 | 0 | 75 |
| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA (Unspecified) |
|
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)
| D018110 | Receptors, Lipoprotein |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| Day 1 |
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| Day 2 |
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| Day 3 |
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| Day 4 |
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| Day 5 |
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| Day 6 |
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| Day 7 |
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| Day 8 |
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| Day 9 |
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| Day 10 |
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| Day 11 |
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| Day 12 |
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| Day 13 |
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| Day 14 |
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| Day 2 |
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| Day 3 |
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| Day 4 |
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| Day 5 |
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| Day 6 |
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| Day 7 |
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| Day 8 |
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| Day 10 |
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| Day 11 |
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| Day 12 |
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| Day 13 |
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| Day 14 |
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| Day 14 |
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| Title | Measurements |
|---|---|
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| Day 7 (n= 75) |
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| Day 14 (n= 74) |
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| Less Bruising |
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| Less Feeling of Pins and Needles |
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| Less Itching |
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| Less Numbness |
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| Less Pain |
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| Less Swelling |
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| Less Tingling |
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| Looks Better |
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| Other |
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| Title | Measurements |
|---|---|
|
| Postoperative Day 14 |
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| Postoperative Day 3 |
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| Postoperative Day 7 |
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| Postoperative Day 14 |
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| Satisfaction with flap adherence FS Side- Day 3 |
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| Satisfaction with flap adherence FS Side- Day 7 |
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| Satisfaction with flap adherence FS Side- Day 14 |
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| Satisfaction with flap adherence SoC Side- Day 1 |
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| Satisfaction with flap adherence SoC Side- Day 3 |
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| Satisfaction with flap adherence SoC Side- Day 7 |
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| Satisfaction with flap adherence SoC Side- Day 14 |
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| Satisfaction with Rate of Healing FS Side- Day 3 |
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| Satisfaction with Rate of Healing FS Side- Day 7 |
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| Satisfaction with Rate of Healing FS Side- Day 14 |
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| Satisfaction with Rate of Healing SoC Side- Day 1 |
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| Satisfaction with Rate of Healing SoC Side- Day 3 |
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| Satisfaction with Rate of Healing SoC Side- Day 7 |
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| Satisfaction with Rate of Healing SoC Side- Day 14 |
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| Satisfaction with Treatment on FS Side- Day 3 |
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| Satisfaction with Treatment on FS Side- Day 7 |
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| Satisfaction with Treatment on FS Side- Day 14 |
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| Satisfaction with Treatment on SoC Side- Day 1 |
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| Satisfaction with Treatment on SoC Side- Day 3 |
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| Satisfaction with Treatment on SoC Side- Day 7 |
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| Satisfaction with Treatment on SoC Side- Day 14 |
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| Day 3 |
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| Day 7 |
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| Day 14 |
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| Serious Adverse Events- Severe |
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| non-Serious Adverse Events- Mild |
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| non-Serious Adverse Events- Moderate |
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| non-Serious Adverse Events- Severe |
|