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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
10
DeNova Research
Chicago, Illinois, United States
Edema Severity
Measured at Day 1, 7, 30, 180 0 None- No apparent edema 1. Mild- Minimal tissue swelling 2. Moderate- Moderate edema, nasal features still discernible 3. Severe- Marked swelling, difficulty distinguishing nasal features Scores closer to 0 indicate more favorable results
Time frame: 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.
Time frame: 1 day, 1 week, 4 weeks and 6 months following surgery
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
Time frame: 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 1. Up to medial one-third of the lower and/or up eyelid Yellowish color change 2. Medial half of the upper and/or lower eyelid Light purple 3. Entire upper and/or lower eyelid Dark purple 4. Entire part of the lower and upper eyelid and/or conjunctiva Very dark purple 5. Extension of ecchymosis below the malar bone Scores closer to 0 indicate a more favorable outcome.
Time frame: 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 1. Up to medial one-third of the lower and/or up eyelid Yellowish color change 2. Medial half of the upper and/or lower eyelid Light purple 3. Entire upper and/or lower eyelid Dark purple 4. Entire part of the lower and upper eyelid and/or conjunctiva Very dark purple 5. Extension of ecchymosis below the malar bone
Time frame: 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.
Time frame: 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
Time frame: 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 1. \- Not at all 2. \- A little bit 3. \- Somewhat 4. \- Very much 5. \- Extremely Scores closer to 100 indicate a more favorable outcome
Time frame: 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
Time frame: Immediately Post Surgery
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