Trial Outcomes & Findings for A Study Evaluating the Efficacy and Safety of ARTISS Human Fibrin Sealant as Used in External Rhinoplasty (NCT NCT01684020)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Measured at Day 1, 7, 30, 180

Results posted on

2020-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	5	5
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study Evaluating the Efficacy and Safety of ARTISS Human Fibrin Sealant as Used in External Rhinoplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ARTISS Human Fibrin Sealant n=5 Participants 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 n=5 Participants Fixation of the skin flap created during external rhinoplasty will use the standard of care	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	45.3 years n=5 Participants	45.3 years n=7 Participants	45.3 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at Day 1, 7, 30, 180

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

Outcome measures

Outcome measures
Measure	ARTISS Human Fibrin Sealant n=5 Participants 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 n=5 Participants Fixation of the skin flap created during external rhinoplasty will use the standard of care
Edema Severity Day 1	1.25 units on a scale Standard Deviation 1.5	1.5 units on a scale Standard Deviation 1.291
Edema Severity Day 7	1.25 units on a scale Standard Deviation 1.5	1 units on a scale Standard Deviation 1.155
Edema Severity Day 30	1 units on a scale Standard Deviation 0.816	1 units on a scale Standard Deviation 1.414
Edema Severity Day 180	1.25 units on a scale Standard Deviation 1.5	0.5 units on a scale Standard Deviation 0.577

PRIMARY outcome

Timeframe: 1 day, 1 week, 4 weeks and 6 months following 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.

Outcome measures

Outcome measures
Measure	ARTISS Human Fibrin Sealant n=5 Participants 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 n=4 Participants Fixation of the skin flap created during external rhinoplasty will use the standard of care
Median Number of Adverse Events	4 number of AE's Interval 2.0 to 6.0	10 number of AE's Interval 8.0 to 15.0

SECONDARY outcome

Timeframe: Measured at Baseline, 1 month, 3 months, 6 months, 12 months

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

Outcome measures

Outcome measures
Measure	ARTISS Human Fibrin Sealant n=5 Participants 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 n=4 Participants Fixation of the skin flap created during external rhinoplasty will use the standard of care
Blinded-assessment of Satisfaction Baseline	4 units on a scale Standard Deviation 0	4 units on a scale Standard Deviation 0
Blinded-assessment of Satisfaction Month 1	2.4 units on a scale Standard Deviation 0.894	2 units on a scale Standard Deviation 0.816
Blinded-assessment of Satisfaction Month 3	2 units on a scale Standard Deviation 0	1 units on a scale Standard Deviation 0
Blinded-assessment of Satisfaction Month 6	1.6 units on a scale Standard Deviation 0.894	1.33 units on a scale Standard Deviation 0.577
Blinded-assessment of Satisfaction Month 12	2.5 units on a scale Standard Deviation 0.707	2 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	ARTISS Human Fibrin Sealant n=5 Participants 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 n=4 Participants Fixation of the skin flap created during external rhinoplasty will use the standard of care
Objective Ecchymosis Evaluation - PI Day 1	1 units on a scale Standard Deviation 1	1.5 units on a scale Standard Deviation 0.577
Objective Ecchymosis Evaluation - PI Week 1	1.4 units on a scale Standard Deviation 0.548	0.75 units on a scale Standard Deviation 0.957
Objective Ecchymosis Evaluation - PI Week 4	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0
Objective Ecchymosis Evaluation - PI Month 6	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	ARTISS Human Fibrin Sealant n=5 Participants 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 n=4 Participants Fixation of the skin flap created during external rhinoplasty will use the standard of care
Subjective Ecchymosis Evaluation - Subject Day 1	1 units on a scale Standard Error 1	2 units on a scale Standard Error 0.778
Subjective Ecchymosis Evaluation - Subject Week 1	1.5 units on a scale Standard Error 0.667	2 units on a scale Standard Error 0.816
Subjective Ecchymosis Evaluation - Subject Week 4	0 units on a scale Standard Error 0	0 units on a scale Standard Error 0
Subjective Ecchymosis Evaluation - Subject Month 6	0 units on a scale Standard Error 0	0 units on a scale Standard Error 0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	ARTISS Human Fibrin Sealant n=5 Participants 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 n=4 Participants Fixation of the skin flap created during external rhinoplasty will use the standard of care
Number of Participants With Adverse Events	1 participants	1 participants

SECONDARY outcome

Timeframe: 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. Downtime scale: (3) Very Much (2) A Lot (1) A Little (0) Not at all Scores closer to 0 indicate more favorable outcome

Outcome measures

Outcome measures
Measure	ARTISS Human Fibrin Sealant n=5 Participants 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 n=4 Participants Fixation of the skin flap created during external rhinoplasty will use the standard of care
Subject Downtime Questionnaire Day 1	3.4 units on a scale Standard Deviation 0.864	4 units on a scale Standard Deviation 0
Subject Downtime Questionnaire Week 1	3.2 units on a scale Standard Deviation 0.447	3.25 units on a scale Standard Deviation 0.5
Subject Downtime Questionnaire Week 4	2.4 units on a scale Standard Deviation 1.14	2 units on a scale Standard Deviation 0.816
Subject Downtime Questionnaire Month 6	1.2 units on a scale Standard Deviation 0.447	1 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 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. 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

Outcome measures

Outcome measures
Measure	ARTISS Human Fibrin Sealant n=5 Participants 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 n=4 Participants Fixation of the skin flap created during external rhinoplasty will use the standard of care
HPSS Assessment Week 1	3.2 units on a scale Standard Deviation 0.447	3.25 units on a scale Standard Deviation 0.5
HPSS Assessment Week 4	2.4 units on a scale Standard Deviation 1.14	2 units on a scale Standard Deviation 0.816
HPSS Assessment Month 6	1.2 units on a scale Standard Deviation 0.447	1 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 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. (10) - Very diffiucult - (100) - Very easy Scores closer to 100 indicate a more favorable outcome

Outcome measures

Outcome measures
Measure	ARTISS Human Fibrin Sealant n=5 Participants 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 n=4 Participants Fixation of the skin flap created during external rhinoplasty will use the standard of care
Ease of Use	17.6 units on a scale Standard Deviation 5.225	39 units on a scale Standard Deviation 17.682

Adverse Events

ARTISS Human Fibrin Sealant

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ARTISS Human Fibrin Sealant n=5 participants at risk 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 n=4 participants at risk Fixation of the skin flap created during external rhinoplasty will use the standard of care
Blood and lymphatic system disorders Ecchymosis	20.0% 1/5 • Number of events 1	25.0% 1/4 • Number of events 1

Additional Information

Steven Dayan, MD

DeNova Research

Phone: 3123352070

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place