A Study Evaluating the Efficacy and Safety of ARTISS Human Fibrin Sealant as Used in External Rhinoplasty
Verified February 2014 by DeNova Research
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Steven H. Dayan, DeNova Research
First received: September 7, 2012
Last updated: February 10, 2014
Last verified: February 2014
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.
Biological: ARTISS human fibrin sealant
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
||A Prospective, Double-Blinded, Randomized Study Evaluating the Efficacy and Safety of ARTISS Human Fibrin Sealant as Used in External Rhinoplasty
Primary Outcome Measures:
- Efficacy [ Time Frame: 4 weeks post-surgery ] [ Designated as safety issue: No ]
Efficacy will be determined by a live assessment of edema at 4 weeks using a four-point categorical scale [(none, mild, moderate, severe)].
- The primary safety endpoint is the incidence of AEs. [ Time Frame: 6 months post surgery ] [ Designated as safety issue: Yes ]
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.
Secondary Outcome Measures:
- Severity of Edema [ Time Frame: 1 day, 1 week, 4 weeks and 6 months ] [ Designated as safety issue: No ]
Edema will be determined by a live assessment at 1 day, 1 week, 4 weeks and 6 months following surgery using a four-point categorical edema scale [none, mild, moderate, severe)].
- Blinded-assessment of satisfaction [ Time Frame: 6 months post surgery ] [ Designated as safety issue: No ]
A non-treating blinded evaluator will assess satisfaction with a four-point categorical satisfaction scale [unsatisfied, satisfied, very satisfied, highly satisfied)] 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.
- Objective Ecchymosis Evaluation [ Time Frame: 1 day, 1 week, 4 weeks and 6 months following surgery ] [ Designated as safety issue: No ]
The surface area and color of ecchymosis will be evaluated using Mirror Software and Vectra 3D photography at 1 day, 1 week, 4 weeks and 6 months following surgery.
- Subjective Ecchymosis Evaluation [ Time Frame: 1 day, 1 week, 4 weeks and 6 months following surgery ] [ Designated as safety issue: No ]
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
- Number of Participants with Adverse Events [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ]
Subjects will complete a 30-day diary documenting adverse events such as erythema, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching and numbness.
- Subject Downtime Questionnaire [ Time Frame: 1 day, 1 week, 4 weeks and 6 months following surgery ] [ Designated as safety issue: No ]
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.
- HPSS Assessment [ Time Frame: 1 week, 4 weeks and 6 months following surgery ] [ Designated as safety issue: No ]
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
- Ease of Use [ Time Frame: Immediately Post Surgery ] [ Designated as safety issue: No ]
Ease of use will be determined by the treating investigator using a 10 cm Visual Analog Scale (VAS) to demonstrate technical ease.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2014 (Final data collection date for primary outcome measure)
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.
Biological: ARTISS human fibrin sealant
No Intervention: Standard of Care
Fixation of the skin flap created during external rhinoplasty will use the standard of care
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01684020
|Chicago, Illinois, United States, 60611 |
|Contact: Tara Davison, BS 312-335-2070 firstname.lastname@example.org |
|Principal Investigator: Steven H Dayan, MD |
Baxter Healthcare Corporation
||Steven H Dayan, MD
No publications provided
||Steven H. Dayan, Medical Director, DeNova Research
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 7, 2012
||February 10, 2014
||United States: Institutional Review Board
Keywords provided by DeNova Research:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 2014
Fibrin Tissue Adhesive