Face-liftPhase 3NCT00999141
Efficacy and Safety of FS VH S/D 4 S-apr for Flap Adherence in Rhytidectomy
A Phase 3 study testing FS VH S/D 4 s-apr in people with Face-lift and Facial Rhytidectomy, run by Baxter Healthcare Corporation at 6 sites in United States.
Trial summary
The purpose of the study is to compare the safety and efficacy of FS VH S/D 4 s-apr versus standard of care in adhering tissue and improving wound healing in subjects undergoing facelift. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Face-lift, Facial Rhytidectomy
- What is being tested?
- FS VH S/D 4 s-apr
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2009to Feb 2010
- Phase
- Phase 3
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subject is 18 to 75 years of age at the time of screening
- Subject is planned for facial rhytidectomy
- Subject has read, understood and signed the written informed consent
- Subject is healthy, as determined by the investigator using standard pre-operative assessments to include laboratory tests and electrocardiograms
- Subject is of childbearing potential, presents with a negative serum pregnancy test, and agrees to employ adequate birth control measures for the duration of the study
- Subject is willing and able to comply with the requirements of the protocol
Who cannot join
- Subject is indicated for an abbreviated or modified face-lift procedure such as deep plane procedures, minimal undermining procedures, thread lifts, and minimal access cranial suspension
- Subject is indicated for concurrent facial surgeries during the operation (eg forehead plasty,blepharoplasty, rhinoplasty, buccal fat removal, any filler injections including fat injections, lip augmentation, skin resurfacing procedures etc.)
- Subject is indicated for additional procedures to the body during the same operation (eg liposuction, mastoplasty etc.)
- Subject has undergone a prior rhytidectomy surgery
- Subject is an active smoker, as assessed by the investigator
- Subject has a known (documented) bleeding or coagulation disorder
Show all 20Show fewer
- Subject is being treated with anti-coagulants or with Aspirin (that was not discontinued 7 days prior to surgery)
- Subject has a vascular disorder, cardiovascular disease, and/or uncontrolled hypertension
- Subject has diabetes mellitus with glycosylated hemoglobin (HbA1c) > 7
- Subject is receiving active treatment for a malignancy
- Subject has a connective tissue disorder
- Subject has an active or chronic skin disorder
- Subject has history of Bell's palsy
- Subject has a documented history of pathologically or pharmacologically induced immune deficiency
- Subject has received chronic treatment with immunosuppressive drugs, systemic corticosteroids, or other chronic treatments within 30 days prior to the surgery
- Subject has a known sensitivity to components of FS VH S/D 4 s-apr
- Subject has a known psychiatric disorder (eg, obsessive compulsive disorder, anxiety, eating disorders, etc.)
- Subject has documented healing complications following previous surgeries (eg, hypertrophic scarring)
- Subject is pregnant or lactating at the time of enrollment
- 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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Atlanta, Georgia
Study site
Beverly Hills, California
Study site
Chattanooga, Tennessee
Study site
Dallas, Texas
Study site
Evans, Georgia
Study site
Hewlett, New York
About this study
Official title: A Randomized, Controlled Phase 3 Study to Evaluate Safety and Efficacy of Fibrin Sealant (FS) VH S/D 4 S-apr (ARTISS) to Adhere Tissues and Improve Wound Healing in Subjects Undergoing Rhytidectomy (Facelift)
The purpose of the study is to compare the safety and efficacy of FS VH S/D 4 s-apr versus standard of care in adhering tissue and improving wound healing in subjects undergoing facelift.
- Conditions
- Face-lift, Facial Rhytidectomy
- Being tested
- FS VH S/D 4 s-apr
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FS VH S/D 4 s-aprBiological
Also called ARTISS
FS VH S/D 4 s-apr will be applied (using spray device provided by Sponsor) to the subcutaneous plane (intraoperative, topical administration) in both the neck and the face area.
| Study group | Role | What they receive |
|---|---|---|
| FS VH S/D 4 s-apr | Experimental | One side of face will be treated with the investigational product (FS VH S/D 4 s-apr) as an adjuvant to the standard of care. Please note: Each subject will participate in both arms (investigational product and standard of care) simultaneously, and will serve as his/her own control. Receives: Biological: FS VH S/D 4 s-apr |
| Standard of Care (SoC) | No intervention | Other side of face will receive standard of care. Please note: Each subject will participate in both arms (investigational product and standard of care) simultaneously, and will serve as his/her own control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Volume of Drainage on Each Side of the Face
Total drainage volume collected from each side of the face. One side of face is treated with FS VH S/D 4 s-apr (FS); the other side is treated using standard of care (SoC).
Measured: 24 hours (± 4h) after surgery
Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr)
Measured: Day 0 (day of surgery) through postoperative Day 14
Secondary outcomes (14)
Participants' First Occurrence of Hematoma or Seroma by Study Day
Investigators assessed each side of the face for the presence of hematomas and/or seromas
Measured: Day 0 (day of surgery) through postoperative day 14
Participants With Hematoma/Seroma by Study Day
Investigators assessed each side of the face for the presence of hematoma and/or seroma
Measured: Day 0 (day of surgery) through postoperative day 14
Number of Participants With Hematoma/Seroma Anytime During the Study
Measured: Day 0 (day of surgery) through postoperative Day 14
Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 1
Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema
Measured: Through postoperative Day 1
Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 3
Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema
Measured: Through postoperative Day 3
Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 7
Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema
Measured: Through postoperative Day 7
Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 14
Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema
Measured: Through postoperative Day 14
Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14
Skin sensitivity was measured using Semmes-Weinstein Monofilament set to detect neurological damage. Filament sizes are noted by handle numbers of measuring tools ([handle number = log10(10*force in milligrams applied to skin)], range = 1.65 to 6.65). Detection of filament with smaller handle number = greater skin sensitivity. Smaller change in filament size detection from pre-op to post-op = less impact to recovery of sensation. Smallest filament felt for each side of face was noted. Change in skin sensitivity computed as (Handle Number Postop Day 3, 7, or 14) - (Handle Number Preop Day 0).
Measured: Day 0 (preoperative) through postoperative Day 14
Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14
Participants responded to the following question during the side of face preference assessment:
"Which side of the face do you prefer? Left side, right side, or no preference?"
Measured: Through postoperative Day 14
Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 1
Participants responded to the following question during the side of face preference assessment:
"Which side of the face do you prefer? Left side, right side, or no preference?"
Measured: Through postoperative Day 1
Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 3
Participants responded to the following question during the side of face preference assessment:
"Which side of the face do you prefer? Left side, right side, or no preference?"
Measured: Through postoperative Day 3
Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 7
Participants responded to the following question during the side of face preference assessment:
"Which side of the face do you prefer? Left side, right side, or no preference?"
Measured: Through postoperative Day 7
Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 14
Participants responded to the following question during the side of face preference assessment:
"Which side of the face do you prefer? Left side, right side, or no preference?"
Measured: Through postoperative Day 14
Reasons for Participants' Preferences for Side of Face
Participants responded to the following questions during the side of face preference assessment:
- "Which side of the face do you prefer? Left side, right side, or no preference?"
- If "right" or "left" is chosen, participants were asked "Please mark ALL reasons for choosing this side"
- Better skin sensation
- Less numbness
- Looks better
- Less bruising
- Less swelling
- Less pain
- Less itching
- Less tingling
- Less feeling of "pins and needles"
- Other ________________ (Free Text)
Measured: Through postoperative Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionFeb 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Face-liftStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve Z Abrams, MD, Study director, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999141
- Sponsor's protocol ID
- 550901
- Status last verified
- Oct 2012
- First submitted
- 20 Oct 2009
- Last updated
- 8 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hester TR Jr, Shire JR, Nguyen DB, Gerut ZE, Chen AH, Diamond J, Desmond JC, Silvati-Fidell L, Abrams SZ, Rohrich RJ. Randomized, controlled, phase 3 study to evaluate the safety and efficacy of fibrin sealant VH S/D 4 s-apr (Artiss) to improve tissue adherence in subjects undergoing rhytidectomy. Aesthet Surg J. 2013 May;33(4):487-96. doi: 10.1177/1090820X13479969. Epub 2013 Apr 5.
PubMed 23563904
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Phase 3 Study to Evaluate Safety and Efficacy of Fibrin Sealant (FS) VH S/D 4 S-apr (ARTISS) to Adhere Tissues and Improve Wound Healing in Subjects Undergoing Rhytidectomy (Facelift)
- ClinicalTrials.gov ID
- NCT00999141
- Acronym / sponsor ID
- 550901
- Conditions
- Face-lift, Facial Rhytidectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 21 Oct 2009 (estimated)
- Results
- Posted 27 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare the safety and efficacy of FS VH S/D 4 s-apr versus standard of care in adhering tissue and improving wound healing in subjects undergoing facelift.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FS VH S/D 4 s-apr | Experimental | Biological: FS VH S/D 4 s-aprOne side of face will be treated with the investigational product (FS VH S/D 4 s-apr) as an adjuvant to the standard of care. Please note: Each subject will participate in both arms (investigational product and standard of care) simultaneously, and will serve as his/her own control. |
| Standard of Care (SoC) | No intervention | –Other side of face will receive standard of care. Please note: Each subject will participate in both arms (investigational product and standard of care) simultaneously, and will serve as his/her own control. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subject is 18 to 75 years of age at the time of screening
- Subject is planned for facial rhytidectomy
- Subject has read, understood and signed the written informed consent
- Subject is healthy, as determined by the investigator using standard pre-operative assessments to include laboratory tests and electrocardiograms
- Subject is of childbearing potential, presents with a negative serum pregnancy test, and agrees to employ adequate birth control measures for the duration of the study
Key exclusion criteria (20 listed)
- Subject is indicated for an abbreviated or modified face-lift procedure such as deep plane procedures, minimal undermining procedures, thread lifts, and minimal access cranial suspension
- Subject is indicated for concurrent facial surgeries during the operation (eg forehead plasty,blepharoplasty, rhinoplasty, buccal fat removal, any filler injections including fat injections, lip augmentation, skin resurfacing procedures etc.)
- Subject is indicated for additional procedures to the body during the same operation (eg liposuction, mastoplasty etc.)
- Subject has undergone a prior rhytidectomy surgery
- Subject is an active smoker, as assessed by the investigator
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 |
|---|---|---|
| FS VH S/D 4 s-aprAlso: ARTISSFS VH S/D 4 s-apr will be applied (using spray device provided by Sponsor) to the subcutaneous plane (intraoperative, topical administration) in both the neck and the face area. | Biological | FS VH S/D 4 s-apr |
Primary outcome
Total Volume of Drainage on Each Side of the Face
Time frame: 24 hours (± 4h) after surgery
Total drainage volume collected from each side of the face. One side of face is treated with FS VH S/D 4 s-apr (FS); the other side is treated using standard of care (SoC).
Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr)
Time frame: Day 0 (day of surgery) through postoperative Day 14
14 secondary outcomes
Participants' First Occurrence of Hematoma or Seroma by Study Day
Time frame: Day 0 (day of surgery) through postoperative day 14
Participants With Hematoma/Seroma by Study Day
Time frame: Day 0 (day of surgery) through postoperative day 14
Number of Participants With Hematoma/Seroma Anytime During the Study
Time frame: Day 0 (day of surgery) through postoperative Day 14
Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 1
Time frame: Through postoperative Day 1
Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 3
Time frame: Through postoperative Day 3
Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 7
Time frame: Through postoperative Day 7
Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 14
Time frame: Through postoperative Day 14
Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14
Time frame: Day 0 (preoperative) through postoperative Day 14
Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14
Time frame: Through postoperative Day 14
Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 1
Time frame: Through postoperative Day 1
Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 3
Time frame: Through postoperative Day 3
Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 7
Time frame: Through postoperative Day 7
Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 14
Time frame: Through postoperative Day 14
Reasons for Participants' Preferences for Side of Face
Time frame: Through postoperative Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23563904Hester TR Jr, Shire JR, Nguyen DB, Gerut ZE, Chen AH, Diamond J, Desmond JC, Silvati-Fidell L, Abrams SZ, Rohrich RJ. Randomized, controlled, phase 3 study to evaluate the safety and efficacy of fibrin sealant VH S/D 4 s-apr (Artiss) to improve tissue adherence in subjects undergoing rhytidectomy. Aesthet Surg J. 2013 May;33(4):487-96. doi: 10.1177/1090820X13479969. Epub 2013 Apr 5.
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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.
Steve Z Abrams, MD study director
Baxter Healthcare Corporation
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FS VH S/D 4 s-apr in people with Face-lift and Facial Rhytidectomy, run by Baxter Healthcare Corporation at 6 sites 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 6 inclusion and 20 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 8 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 27 Aug 2012). 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?
Total Volume of Drainage on Each Side of the Face (time frame: 24 hours (± 4h) after surgery). 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 NCT00999141, which also lists 1 linked publication.
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 8 Oct 2012.