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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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Rhinoplasty (nasal reconstruction i.e. "a nose job") is a surgical procedure performed on the nose to correct a medical problem or change the appearance of the nose. During the healing process, swelling and/or bruising is likely to occur. A drug called ARTISS Fibrin Sealant may or may not lessen these effects. This study is looking to see the effects of ARTISS on adhering tissue and improving wound healing in an external rhinoplasty. The purpose of this study is to evaluate the safety and effectiveness of rhinoplasty using ARTISS compared to rhinoplasty without using ARTISS in patients undergoing rhinoplasty performed through an external approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARTISS Human Fibrin Sealant | Experimental | Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes. |
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| Standard of Care | No Intervention | Fixation of the skin flap created during external rhinoplasty will use the standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARTISS human fibrin sealant | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| Edema Severity | Measured at Day 1, 7, 30, 180 0 None- No apparent edema
Scores closer to 0 indicate more favorable results | Measured at Day 1, 7, 30, 180 |
| Median Number of Adverse Events | Safety will be assessed by the incidence of AEs throughout the study period as documented by clinician observations at study visits and in a 30-day subject diary. | 1 day, 1 week, 4 weeks and 6 months following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Blinded-assessment of Satisfaction | A non-treating blinded evaluator will assess satisfaction with a four-point categorical satisfaction scale [unsatisfied (4), satisfied (3), very satisfied (2), highly satisfied (1))] of subject's grafts using photographs from baseline, 1 month, 3 months, 6 months, and 12 months and will consist of a blinded evaluation in which the physician is aware of the type of graft, but unaware of plating status or the specific grafting site. Scores closer to 1 indicate a more favorable outcome |
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Inclusion Criteria:
Males and females between 18 and 65 years of age.
Subjects requesting primary rhinoplasty and requiring an external approach.
Subjects willing to undergo treatment with fibrin sealant.
Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
Willingness and ability to comply with the PI's standard preoperative and postoperative rhinoplasty instructions.
Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following is documented on the medical history:
Willingness and ability to provide written photo consent and adherence to photography procedures (i.e., removal of jewelry and makeup).
Willingness and ability to provide written informed consent prior to performance of any study related procedure.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven H Dayan, MD | DeNova Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DeNova Research | Chicago | Illinois | 60611 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | ARTISS Human Fibrin Sealant | Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes. ARTISS human fibrin sealant |
| FG001 | Standard of Care | Fixation of the skin flap created during external rhinoplasty will use the standard of care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | ARTISS Human Fibrin Sealant | Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes. ARTISS human fibrin sealant |
| BG001 | Standard of Care |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Edema Severity | Measured at Day 1, 7, 30, 180 0 None- No apparent edema
Scores closer to 0 indicate more favorable results | Posted | Mean | Standard Deviation | units on a scale | Measured at Day 1, 7, 30, 180 |
|
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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 | ARTISS Human Fibrin Sealant | Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes. ARTISS human fibrin sealant |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ecchymosis | Blood and lymphatic system disorders | Systematic Assessment | A discoloration of the skin resulting from bleeding underneath, typically caused by bruising |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Dayan, MD | DeNova Research | 3123352070 | sdayan@drdayan.com |
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| Measured at Baseline, 1 month, 3 months, 6 months, 12 months |
| Objective Ecchymosis Evaluation - PI | The surface area and color of ecchymosis will be evaluated at 1 day, 1 week, 4 weeks, and 6 months following surgery. Rating Extent Color 0 No ecchymosis No color change
Scores closer to 0 indicate a more favorable outcome. | 6 months |
| Subjective Ecchymosis Evaluation - Subject | Ecchymosis will be determined by a live assessment at 1 day, 1 week, 4 weeks and 6 months following surgery using a six-point categorical edema scale. Rating Extent Color 0 No ecchymosis No color change
| 6 months |
| Number of Participants With Adverse Events | Subjects will complete a 30-day diary documenting adverse events such as erythema, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching and numbness. | Day 30 |
| Subject Downtime Questionnaire | Subject downtime will be determined using a questionnaire at 1 day, 1 week, 4 weeks, and 6 months following surgery. Responders are defined as those subjects experiencing little to no downtime. Downtime scale: (3) Very Much (2) A Lot (1) A Little (0) Not at all Scores closer to 0 indicate more favorable outcome | 1 day, 1 week, 4 weeks and 6 months following surgery |
| HPSS Assessment | Changes in subject self-esteem will be determined by subject completion of the Heatherton & Polivy State Self-Esteem (HPSS) Scale at 1 week, 4 weeks and 6 months following surgery. HPSS: scored between 1-5 for 20 questions with a total possible score between 20-100
Scores closer to 100 indicate a more favorable outcome | 1 week, 4 weeks and 6 months following surgery |
| Ease of Use | Ease of use will be determined by the treating investigator using a 10 cm Visual Analog Scale (VAS) to demonstrate technical ease. (10) - Very diffiucult - (100) - Very easy Scores closer to 100 indicate a more favorable outcome | Immediately Post Surgery |
Fixation of the skin flap created during external rhinoplasty will use the standard of care |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Median Number of Adverse Events | Safety will be assessed by the incidence of AEs throughout the study period as documented by clinician observations at study visits and in a 30-day subject diary. | Posted | Mean | Full Range | number of AE's | 1 day, 1 week, 4 weeks and 6 months following surgery |
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| Secondary | Blinded-assessment of Satisfaction | A non-treating blinded evaluator will assess satisfaction with a four-point categorical satisfaction scale [unsatisfied (4), satisfied (3), very satisfied (2), highly satisfied (1))] of subject's grafts using photographs from baseline, 1 month, 3 months, 6 months, and 12 months and will consist of a blinded evaluation in which the physician is aware of the type of graft, but unaware of plating status or the specific grafting site. Scores closer to 1 indicate a more favorable outcome | Posted | Mean | Standard Deviation | units on a scale | Measured at Baseline, 1 month, 3 months, 6 months, 12 months |
|
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| Secondary | Objective Ecchymosis Evaluation - PI | The surface area and color of ecchymosis will be evaluated at 1 day, 1 week, 4 weeks, and 6 months following surgery. Rating Extent Color 0 No ecchymosis No color change
Scores closer to 0 indicate a more favorable outcome. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | Subjective Ecchymosis Evaluation - Subject | Ecchymosis will be determined by a live assessment at 1 day, 1 week, 4 weeks and 6 months following surgery using a six-point categorical edema scale. Rating Extent Color 0 No ecchymosis No color change
| Posted | Mean | Standard Error | units on a scale | 6 months |
|
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| Secondary | Number of Participants With Adverse Events | Subjects will complete a 30-day diary documenting adverse events such as erythema, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching and numbness. | Posted | Number | participants | Day 30 |
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| Secondary | Subject Downtime Questionnaire | Subject downtime will be determined using a questionnaire at 1 day, 1 week, 4 weeks, and 6 months following surgery. Responders are defined as those subjects experiencing little to no downtime. Downtime scale: (3) Very Much (2) A Lot (1) A Little (0) Not at all Scores closer to 0 indicate more favorable outcome | Posted | Mean | Standard Deviation | units on a scale | 1 day, 1 week, 4 weeks and 6 months following surgery |
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| Secondary | HPSS Assessment | Changes in subject self-esteem will be determined by subject completion of the Heatherton & Polivy State Self-Esteem (HPSS) Scale at 1 week, 4 weeks and 6 months following surgery. HPSS: scored between 1-5 for 20 questions with a total possible score between 20-100
Scores closer to 100 indicate a more favorable outcome | Posted | Mean | Standard Deviation | units on a scale | 1 week, 4 weeks and 6 months following surgery |
|
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| Secondary | Ease of Use | Ease of use will be determined by the treating investigator using a 10 cm Visual Analog Scale (VAS) to demonstrate technical ease. (10) - Very diffiucult - (100) - Very easy Scores closer to 100 indicate a more favorable outcome | Posted | Mean | Standard Deviation | units on a scale | Immediately Post Surgery |
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| 0 |
| 5 |
| 0 |
| 5 |
| 1 |
| 5 |
| EG001 | Standard of Care | Fixation of the skin flap created during external rhinoplasty will use the standard of care | 0 | 4 | 0 | 4 | 1 | 4 |
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