A Study Evaluating the Efficacy and Safety of ARTISS Human Fibrin Sealant as Used in External Rhinoplasty
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|ClinicalTrials.gov Identifier: NCT01684020|
Recruitment Status : Completed
First Posted : September 12, 2012
Last Update Posted : February 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Subjects Requesting and Requiring an Open Rhinoplasty||Biological: ARTISS human fibrin sealant||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Prospective, Double-Blinded, Randomized Study Evaluating the Efficacy and Safety of ARTISS Human Fibrin Sealant as Used in External Rhinoplasty|
|Actual Study Start Date :||November 28, 2012|
|Actual Primary Completion Date :||April 26, 2016|
|Actual Study Completion Date :||April 26, 2016|
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
- Efficacy [ Time Frame: 4 weeks post-surgery ]Edema [(none, mild, moderate, severe)].
- The primary safety endpoint is the incidence of AEs. [ Time Frame: 6 months post 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.
- Severity of Edema [ Time Frame: 1 day, 1 week, 4 weeks and 6 months ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]Ease of use will be determined by the treating investigator using a 10 cm Visual Analog Scale (VAS) to demonstrate technical ease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684020
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Steven H Dayan, MD||DeNova Research|