A Study Evaluating the Efficacy and Safety of ARTISS Human Fibrin Sealant as Used in External Rhinoplasty
NCT ID: NCT01684020
Last Updated: 2020-11-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2012-11-28
2016-04-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
Standard of Care
Fixation of the skin flap created during external rhinoplasty will use the standard of care
No interventions assigned to this group
Interventions
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ARTISS human fibrin sealant
Eligibility Criteria
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Inclusion Criteria
2. Subjects requesting primary rhinoplasty and requiring an external approach.
3. Subjects willing to undergo treatment with fibrin sealant.
4. 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.
5. Willingness and ability to comply with the PI's standard preoperative and postoperative rhinoplasty instructions.
6. 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
7. Willingness and ability to provide written photo consent and adherence to photography procedures (i.e., removal of jewelry and makeup).
8. Willingness and ability to provide written informed consent prior to performance of any study related procedure.
Exclusion Criteria
2. 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.).
3. Subjects with a previous history of rhinoplasty.
4. Subjects with a current history of smoking.
5. Subjects with a previous history of a bleeding or coagulation disorder .
6. Subject with a previous history of a vascular disorder, cardiovascular disease, and/or uncontrolled hypertension.
7. Subjects a previous history of diabetes mellitus with glycosylated hemoglobin (HbA1c) \> 7.
8. Subjects undergoing active treatment for a malignancy.
9. Subjects with a previous history of has a connective tissue disorder.
10. Subjects with active or chronic skin disorder.
11. Subjects with a previous history of Bell's palsy.
12. Subjects with a previous history of pathologically or pharmacologically induced immune deficiency.
13. Subjects who have received chronic treatment with immunosuppressive drugs, systemic corticosteroids, or other chronic treatments within 30 days prior to the surgery.
14. Subjects with a known sensitivity to components of FS VH S/D 4 s-apr.
15. Subjects with a previous history of healing complications following previous surgeries (eg, hypertrophic scarring).
16. Subjects with a significant systemic illness or illness localized to the areas of treatment.
17. Subjects with previous history of nasal implants.
18. Subjects with previous or current history of nasal infections.
19. Subjects who have history of blood thinners (aspirin, ibuprofen, naprosyn, herbal supplements, Vitamin E) within the two weeks prior to surgery.
20. Subjects who have smoked within the two weeks prior to surgery.
21. Subjects who have had alcohol or illicit drugs one week prior to surgery.
22. Subjects who have eaten or drank anything after midnight the night prior to surgery.
23. Subjects with current history of chronic drug or alcohol abuse.
24. Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
25. Subjects who anticipate the need for surgery, other than the study procedure, or overnight hospitalization during the study.
26. Subjects who, in the Investigator's opinion, have a history of poor cooperation, non compliance with medical treatment or unreliability.
27. 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
18 Years
65 Years
ALL
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
DeNova Research
OTHER
Responsible Party
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Steven H. Dayan
Medical Director
Principal Investigators
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Steven H Dayan, MD
Role: PRINCIPAL_INVESTIGATOR
DeNova Research
Locations
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DeNova Research
Chicago, Illinois, United States
Countries
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Related Links
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Related Info
Other Identifiers
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ART-RHI-12
Identifier Type: -
Identifier Source: org_study_id