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

NCT01684020 | Completed Phase 2 Results

• 1 other identifier: ART-RHI-12
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

rhinoplasty; external rhinoplasty; open rhinoplasty; nose job

Outcome Measures

Primary Outcomes (2)

• 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 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.

  1 day, 1 week, 4 weeks and 6 months following surgery

Secondary Outcomes (7)

• Blinded-assessment of Satisfaction

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

• Objective Ecchymosis Evaluation - PI

  6 months

• Subjective Ecchymosis Evaluation - Subject

  6 months

• Number of Participants With Adverse Events

  Day 30

• Subject Downtime Questionnaire

  1 day, 1 week, 4 weeks and 6 months following surgery

Study Arms (2)

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.

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

Interventions

ARTISS human fibrin sealant BIOLOGICAL

ARTISS Human Fibrin Sealant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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:
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• DeNova Research: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

DeNova Research

Chicago, Illinois, 60611, United States

Location

Related Links

• Related Info

Results Point of Contact

• Title: Steven Dayan, MD
• Organization: DeNova Research

sdayan@drdayan.com

3123352070

Study Officials

• Steven H Dayan, MD

  DeNova Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: September 7, 2012
• First Posted: September 12, 2012
• Study Start: November 28, 2012
• Primary Completion: April 26, 2016
• Study Completion: April 26, 2016
• Last Updated: November 2, 2020
• Results First Posted: October 14, 2020

Record last verified: 2020-10

Locations

US (1)