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
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
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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California
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Beverly Hills, California, Forenede Stater
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Los Angeles, California, Forenede Stater
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Georgia
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Atlanta, Georgia, Forenede Stater
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Evans, Georgia, Forenede Stater
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New York
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Hewlett, New York, Forenede Stater
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Tennessee
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Chattanooga, Tennessee, Forenede Stater
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 1
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.
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Each subject received fibrin sealant with 4 IU/mL thrombin, vapor heated, solvent detergent treated containing synthetic aprotinin (FS VH S/D 4 ) to one side of the face.
The dosing volume to be applied is 0.02 mL/cm2 to 0.04 mL/cm2.
The study product will be applied to the subcutaneous plane in both the neck and the face area.
The product will be applied using the spray device provided by the sponsor.
(The other side of the face will be treated using standard of care.)
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Visual Comparison of Ecchymosis at Postoperative Day 3
Tidsramme: Through Postoperative Day 3
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Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.
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Through Postoperative Day 3
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Incidence of Adverse Events (AEs) Related to Study Product (FS VH S/D 4) Throughout the Study Period
Tidsramme: Through Postoperative Day 14 (± 1)
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Through Postoperative Day 14 (± 1)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Visual Comparison of Ecchymosis at Day 1
Tidsramme: Through Postoperative Day 1
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Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.
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Through Postoperative Day 1
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Visual Comparison of Ecchymosis at Day 5
Tidsramme: Through Postoperative Day 5
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Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.
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Through Postoperative Day 5
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Visual Comparison of Ecchymosis at Day 7
Tidsramme: Through Postoperative Day 7
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Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.
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Through Postoperative Day 7
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Visual Comparison of Ecchymosis at Day 10
Tidsramme: Through Postoperative Day 10
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Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.
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Through Postoperative Day 10
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Visual Comparison of Ecchymosis at Day 14
Tidsramme: Through Postoperative Day 14
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Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.
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Through Postoperative Day 14
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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
Tidsramme: Through Postoperative Day 1
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Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved Statistical Analysis Plan (SAP) specified 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. |
Through Postoperative Day 1
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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
Tidsramme: Through Postoperative Day 3
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Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified 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. |
Through Postoperative Day 3
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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
Tidsramme: Through Postoperative Day 5
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Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified 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. |
Through Postoperative Day 5
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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
Tidsramme: Through Postoperative Day 7
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Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified 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. |
Through Postoperative Day 7
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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
Tidsramme: Through Postoperative Day 10
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Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified 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. |
Through Postoperative Day 10
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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
Tidsramme: Through Postoperative Day 14
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Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified 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. |
Through Postoperative Day 14
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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
Tidsramme: Postoperative Day 3
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Difference between each side of the face are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified 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. |
Postoperative Day 3
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Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 1
Tidsramme: Through Postoperative Day 1
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Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil, Grade 2= Minor, Grade 3= Moderate, Grade 4= Marked/unusual amount. The planned and approved SAP specified 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. |
Through Postoperative Day 1
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Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 3
Tidsramme: Through Postoperative Day 3
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Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount. The planned and approved SAP specified 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. |
Through Postoperative Day 3
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Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 5
Tidsramme: Through Postoperative Day 5
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Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount. The planned and approved SAP specified 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. |
Through Postoperative Day 5
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Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 7
Tidsramme: Through Postoperative Day 7
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Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount. The planned and approved SAP specified 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. |
Through Postoperative Day 7
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Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 10
Tidsramme: Through Postoperative Day 10
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Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount. The planned and approved SAP specified 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. |
Through Postoperative Day 10
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Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 14
Tidsramme: Through Postoperative Day 14
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Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount. The planned and approved SAP specified 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. |
Through Postoperative Day 14
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Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 1
Tidsramme: Through Postoperative Day 1
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Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color) The planned and approved SAP specified 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. |
Through Postoperative Day 1
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Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 3
Tidsramme: Through Postoperative Day 3
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Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color) The planned and approved SAP specified 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. |
Through Postoperative Day 3
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Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 5
Tidsramme: Through Postoperative Day 5
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Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color) The planned and approved SAP specified 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. |
Through Postoperative Day 5
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Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 7
Tidsramme: Through Postoperative Day 7
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Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color) The planned and approved SAP specified 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. |
Through Postoperative Day 7
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Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 10
Tidsramme: Through Postoperative Day 10
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Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color) The planned and approved SAP specified 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. |
Through Postoperative Day 10
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Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 14
Tidsramme: Through Postoperative Day 14
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Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color) The planned and approved SAP specified 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. |
Through Postoperative Day 14
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Resolution of Ecchymosis as Assessed by Investigators
Tidsramme: Postoperative Days 1, 3, 5, 7, 10, and 14
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Resolution of ecchymosis (grade 0 on the Modified Marchac Scale for ecchymosis (Grade 0 = No bruising at all))
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Postoperative Days 1, 3, 5, 7, 10, and 14
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Resolution of Edema as Assessed by Investigators.
Tidsramme: Postoperative Days 1, 3, 5, 7, 10, and 14
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Resolution of edema (grade 1 on the Marchac Scale for Edema (Grade 1 = Nil)
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Postoperative Days 1, 3, 5, 7, 10, and 14
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Total Volume of Drainage on Each Side of the Face
Tidsramme: 24 hours postoperative
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24 hours postoperative
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Participants With Hematoma/Seroma
Tidsramme: Days 0, 1, 3, 5, 7,10, and 14
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Investigators assessed each side of the face for the presence of hematoma/seroma
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Days 0, 1, 3, 5, 7,10, and 14
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Participants With Hematoma/Seroma During the Study
Tidsramme: Through Postoperative Day 14 (± 1)
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Investigators assessed each side of the face for the presence of hematoma/seroma
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Through Postoperative Day 14 (± 1)
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Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14
Tidsramme: Postoperative Days 3, 7, 10, and 14
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Two-point discrimination test performed by investigators to assess nerve regeneration.
Testing performed on each side of the face (SoC and FS VH S/D 4).
Differences are calculated as: Postoperative Day - Day 0, reported as minimal distance at which participants were able to discern feeling at two distinct points
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Postoperative Days 3, 7, 10, and 14
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Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4)
Tidsramme: Days 1, 3, 5, 7,10, and 14
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Differences are calculated as (Grade for SoC) - (Grade for FS VH S/D 4). Participants used a 10-point visual analogue scale to complete a pain assessment for each side of their face during each postoperative study visit (Days 1, 3, 5, 7, 10, and 14). The higher the number, the greater the pain experienced, i.e. 10 = worst, 1 = least. The planned and approved SAP specified 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. |
Days 1, 3, 5, 7,10, and 14
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Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4)
Tidsramme: Days 1, 3, 5, 7,10, and 14
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Differences are calculated as (Grade for SoC) - (Grade for FS VH S/D 4). Participants used a 10-point visual analogue scale to complete a numbness assessment for each side of their face during each postoperative study visit (Days 1, 3, 5, 7, 10, and 14). The higher the number, the greater the numbness experienced, i.e. 10 = worst, 1 = least. The planned and approved SAP specified 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. |
Days 1, 3, 5, 7,10, and 14
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Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4)
Tidsramme: Postoperative Days 1, 3, 5, 7, 10, and 14
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Participants compared the levels of bruising on each side of their face and determine if they had a preference for the look of 1 side over another.
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Postoperative Days 1, 3, 5, 7, 10, and 14
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Steve Z Abrams, MD, Baxter Healthcare Corporation
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 550703
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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