- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01684020
A Study Evaluating the Efficacy and Safety of ARTISS Human Fibrin Sealant as Used in External Rhinoplasty
A Prospective, Double-Blinded, Randomized Study Evaluating the Efficacy and Safety of ARTISS Human Fibrin Sealant as Used in External Rhinoplasty
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
Illinois
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Chicago, Illinois, United States, 60611
- DeNova Research
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- postmenopausal for at least 12 months prior to study drug administration
- without a uterus and/or both ovaries
- has had a bilateral tubal ligation for at least 6 months prior to study drug administration.
- absence of an other physical condition according to the PI's discretion
- 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:
- Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control.
- Subjects who are planning a concurrent facial surgery during the operation (eg forehead plasty, blepharoplasty, rhinoplasty, buccal fat removal, any filler injections including fat injections, lip augmentation, skin resurfacing procedures etc.).
- Subjects with a previous history of rhinoplasty.
- Subjects with a current history of smoking.
- Subjects with a previous history of a bleeding or coagulation disorder .
- Subject with a previous history of a vascular disorder, cardiovascular disease, and/or uncontrolled hypertension.
- Subjects a previous history of diabetes mellitus with glycosylated hemoglobin (HbA1c) > 7.
- Subjects undergoing active treatment for a malignancy.
- Subjects with a previous history of has a connective tissue disorder.
- Subjects with active or chronic skin disorder.
- Subjects with a previous history of Bell's palsy.
- Subjects with a previous history of pathologically or pharmacologically induced immune deficiency.
- Subjects who have received chronic treatment with immunosuppressive drugs, systemic corticosteroids, or other chronic treatments within 30 days prior to the surgery.
- Subjects with a known sensitivity to components of FS VH S/D 4 s-apr.
- Subjects with a previous history of healing complications following previous surgeries (eg, hypertrophic scarring).
- Subjects with a significant systemic illness or illness localized to the areas of treatment.
- Subjects with previous history of nasal implants.
- Subjects with previous or current history of nasal infections.
- Subjects who have history of blood thinners (aspirin, ibuprofen, naprosyn, herbal supplements, Vitamin E) within the two weeks prior to surgery.
- Subjects who have smoked within the two weeks prior to surgery.
- Subjects who have had alcohol or illicit drugs one week prior to surgery.
- Subjects who have eaten or drank anything after midnight the night prior to surgery.
- Subjects with current history of chronic drug or alcohol abuse.
- Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
- Subjects who anticipate the need for surgery, other than the study procedure, or overnight hospitalization during the study.
- Subjects who, in the Investigator's opinion, have a history of poor cooperation, non compliance with medical treatment or unreliability.
- Subject has participated in another clinical study involving an investigational product/device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational product/device during the course of this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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|
No Intervention: Standard of Care
Fixation of the skin flap created during external rhinoplasty will use the standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Edema Severity
Time Frame: Measured at Day 1, 7, 30, 180
|
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
Time Frame: 1 day, 1 week, 4 weeks and 6 months following surgery
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blinded-assessment of Satisfaction
Time Frame: Measured at Baseline, 1 month, 3 months, 6 months, 12 months
|
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 |
Measured at Baseline, 1 month, 3 months, 6 months, 12 months
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Objective Ecchymosis Evaluation - PI
Time Frame: 6 months
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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
Time Frame: 6 months
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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
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6 months
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Number of Participants With Adverse Events
Time Frame: Day 30
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Subjects will complete a 30-day diary documenting adverse events such as erythema, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching and numbness.
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Day 30
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Subject Downtime Questionnaire
Time Frame: 1 day, 1 week, 4 weeks and 6 months following surgery
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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
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HPSS Assessment
Time Frame: 1 week, 4 weeks and 6 months following surgery
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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
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Ease of Use
Time Frame: Immediately Post Surgery
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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
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ART-RHI-12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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