A Study Evaluating the Efficacy and Safety of ARTISS Human Fibrin Sealant as Used in External Rhinoplasty
|ClinicalTrials.gov Identifier: NCT01684020|
Recruitment Status : Unknown
Verified September 2014 by Steven H. Dayan, DeNova Research.
Recruitment status was: Recruiting
First Posted : September 12, 2012
Last Update Posted : September 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Rhinoplasty||Biological: ARTISS human fibrin sealant||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated 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|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||November 2014|
|Estimated Study Completion Date :||July 2015|
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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684020
|Contact: Katherine Cho, MPHemail@example.com|
|Contact: Selika Gutierrez- Borst, MS, RNfirstname.lastname@example.org|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Katherine Cho, MPH 312-335-2070 email@example.com|
|Principal Investigator: Steven H Dayan, MD|
|Principal Investigator:||Steven H Dayan, MD||DeNova Research|