Subjects Requesting and Requiring an Open RhinoplastyPhase 2NCT01684020

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

A Phase 2 study testing ARTISS human fibrin sealant in people with Subjects Requesting and Requiring an Open Rhinoplasty, run by DeNova Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Subjects Requesting and Requiring an Open Rhinoplasty
What is being tested?: ARTISS human fibrin sealant
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 28 Nov 2012to 26 Apr 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

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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.

Who cannot join

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.

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

DeNova Research
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: A Prospective, Double-Blinded, Randomized Study Evaluating the Efficacy and Safety of ARTISS Human Fibrin Sealant as Used in External Rhinoplasty

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.

Conditions: Subjects Requesting and Requiring an Open Rhinoplasty
Being tested: ARTISS human fibrin sealant
Keywords: rhinoplasty, external rhinoplasty, open rhinoplasty, nose job

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ARTISS human fibrin sealantBiological

Study groups in NCT01684020
Study group	Role	What they receive
ARTISS Human Fibrin Sealant	Experimental	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. Receives: Biological: ARTISS human fibrin sealant
Standard of Care	No intervention	Fixation of the skin flap created during external rhinoplasty will use the standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Immediately Post Surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Nov 201226 Apr 2016

First posted12 Sep 2012 (estimated)
Study start28 Nov 2012
Primary completion26 Apr 2016
Study completion26 Apr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Subjects Requesting and Requiring an Open RhinoplastyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01684020
Sponsor's protocol ID: ART-RHI-12
Status last verified: Oct 2020
First submitted: 7 Sep 2012
Last updated: 2 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Double-Blinded, Randomized Study Evaluating the Efficacy and Safety of ARTISS Human Fibrin Sealant as Used in External Rhinoplasty
ClinicalTrials.gov ID: NCT01684020
Acronym / sponsor ID: ART-RHI-12
Conditions: Subjects Requesting and Requiring an Open Rhinoplasty
Keywords: rhinoplasty, external rhinoplasty, open rhinoplasty, nose job
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: DeNova ResearchUniversity, hospital or other
Collaborators: Baxter Healthcare Corporation
Study start: 28 Nov 2012 (actual)
Primary completion: 26 Apr 2016 (actual)
Study completion: 26 Apr 2016 (actual)
First posted: 12 Sep 2012 (estimated)
Results: Posted 14 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ARTISS Human Fibrin Sealant	Experimental	Biological: ARTISS human fibrin sealantPrior 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.
Standard of Care	No intervention	–Fixation of the skin flap created during external rhinoplasty will use the standard of care

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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.

Key exclusion criteria (27 listed)

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 .

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ARTISS human fibrin sealant	Biological	ARTISS Human Fibrin Sealant

Primary outcome

Edema Severity
Time frame: 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
Median Number of Adverse Events
Time frame: 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.

7 secondary outcomes

Blinded-assessment of Satisfaction
Time frame: Measured at Baseline, 1 month, 3 months, 6 months, 12 months
Objective Ecchymosis Evaluation - PI
Time frame: 6 months
Subjective Ecchymosis Evaluation - Subject
Time frame: 6 months
Number of Participants With Adverse Events
Time frame: Day 30
Subject Downtime Questionnaire
Time frame: 1 day, 1 week, 4 weeks and 6 months following surgery
HPSS Assessment
Time frame: 1 week, 4 weeks and 6 months following surgery
Ease of Use
Time frame: Immediately Post Surgery

Results and safety

Results posted to the registry on 14 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ARTISS Human Fibrin Sealant	5	4
Standard of Care	5	5

Primary outcome: Edema Severity

Time frame: Measured at Day 1, 7, 30, 180. Mean (Standard Deviation). Unit: units on a scale

Measure	ARTISS Human Fibrin Sealant n = 5	Standard of Care n = 5
Day 1	1.25 (1.5)	1.5 (1.291)
Day 7	1.25 (1.5)	1 (1.155)
Day 30	1 (0.816)	1 (1.414)
Day 180	1.25 (1.5)	0.5 (0.577)

Primary outcome: Median Number of Adverse Events

Time frame: 1 day, 1 week, 4 weeks and 6 months following surgery. Mean (Full Range). Unit: number of AE's

Measure	ARTISS Human Fibrin Sealant n = 5	Standard of Care n = 4
Value	4 (2 to 6)	10 (8 to 15)

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ARTISS Human Fibrin Sealant	0 of 5 (0%)	1 of 5 (20%)	0 of 5
Standard of Care	0 of 4 (0%)	1 of 4 (25%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steven H Dayan, MD principal investigator

DeNova Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ARTISS human fibrin sealant in people with Subjects Requesting and Requiring an Open Rhinoplasty, run by DeNova Research at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Edema Severity (time frame: Measured at Day 1, 7, 30, 180). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01684020.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.