SeromaPhase 2NCT01112735
Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty
A Phase 2 study testing FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma) in people with Seroma and Hematoma, 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 ARTISS versus standard of care in adhering tissue places and reducing seroma/hematoma formation in subjects undergoing abdominoplasty. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- What is being tested?
- FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2010to Feb 2011
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is 18 to 75 years of age at the time of screening
- Subject is planned for primary standard abdominoplasty (status post Cesarean section or liposuction performed more than 6 months prior to enrollment in the study are allowed)
- If the subject is of childbearing potential; presents with a negative pregnancy test, and agrees to employ adequate birth control measures for the duration of the study
- Subject resides within 100 miles of the investigational site and is willing and able to comply with the scheduling requirements of the protocol (notably home visits by study personnel)
- Subject is willing and able to comply with the requirements of the protocol
Who cannot join
- Subject is obese (body mass index [BMI] > 30 before surgery)
- Subject has experienced massive weight loss (subject has a history of obesity during adult life; subject lost more than 20 BMI unit score, subject has undergone a bariatric surgery)
- Subject has a history of active smoking within the previous 12 months
- Subject is elected for a non-standard abdominoplasty (extended, limited or mini-abdominoplasty, endoscopic, fleur-de-lis or circumferential abdominoplasty) or panniculectomy
- Subject has scars on the abdominal wall above the umbilicus. Vertical midline, laparoscopic punctures, or liposuction punctures are permitted
- Subject is planned for other "body lifting" procedures (eg to the arms, legs, back etc.)
Show all 23Show fewer
- Subject is planned for combined abdominoplasty with other cosmetic procedures including liposuction (restricted liposuction of the waist line and the lower back is allowed, as long as the integrity of the surgical spaces is maintained)
- Subject has an active or chronic skin disorder, history or evidence of keloid formation, or hypertrophic scarring
- Subject has a history of gastrointestinal disorders (eg Irritable Bowel Syndrome) requiring prescription medications
- Subject has a known abdominal hernia that requires mesh fixation
- Subject has a documented hiatal hernia or acid reflux disease
- Subjects with congenital or acquired immunodeficiency disorders
- Subject has uncontrolled diabetes mellitus (HbA1c > 7.0)
- Subject has a history of cardio-vascular disease including uncontrolled hypertension (> 140/90 mm Hg)
- Subject has a clinically diagnosed psychiatric disorder (including obsessive compulsive disorders)
- Subject has a known (documented) bleeding or coagulation disorder including history of thromboembolic events
- Subject is being treated with anti-coagulants or with Aspirin (that was not discontinued 7 days prior to surgery)
- Subject is receiving active treatment for a malignancy
- Subject has a connective tissue disorder
- Subject has received chronic treatment with immunosuppressive drugs, systemic corticosteroids, or other chronic treatments within 30 days prior to the surgery
- Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
- Subject has a known sensitivity to fibrin sealants
- Subject is a friend, employee, or relative of the investigator or other study personnel
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Places Plastic Surgery
Atlanta, Georgia, 30327
Mei Li Surgery Center
Beverly Hills, California, 90210
The Practice of Gary Wiesman, M.D. and Irvin Wiesman, M.D. and Associates
Chicago, Illinois, 60654
UT Southwestern Medical Center, Department of Plastic Surgery
Dallas, Texas, 75390-9132
Center for Plastic Surgery and Skin Care
Fort Lauderdale, Florida, 33308
Miami Plastic Surgery
Miami, Florida, 33176
About this study
Official title: A Randomized, Controlled, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of ARTISS (FS VH S/D 4 S-apr) for Flap Adherence in Subjects Undergoing Abdominoplasty
The purpose of the study is to compare the safety and efficacy of ARTISS versus standard of care in adhering tissue places and reducing seroma/hematoma formation in subjects undergoing abdominoplasty.
- Being tested
- FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma), Standard of care
- Keywords
- Abdominoplasty, Flap adherence in subjects undergoing abdominoplasty to eliminate dead space and reduce seroma/hematoma formation
- Medical subject headings
- Seroma, Hematoma
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-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma)Biological
Also called ARTISS
Dosage form: spray (aerosolized sealant), Dosage frequency: once (1 layer). ARTISS will be applied onto the fascia or the wound bed.
Standard of careProcedure or surgery
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| ARTISS | Experimental | ARTISS will be used as an adjuvant to standard of care. Receives: Biological: FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma) |
| Standard of care | Other | Standard of care Receives: Procedure: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Drainage Volume Collected Until Drain Removal
Drainage fluids were to be collected through the Blake drain and into the collection bulb. The drainage volume was measured and recorded daily until the removal of the drain. During scheduled visits, measurement was to be performed at the study site, and on non-visit day recording of the drainage volume was to be done by a visiting home care nurse (or other study personnel). The drain was ready to be removed when the drainage volume in a given 24 hour period was <=30 cc.
Measured: Day 0 (Surgery Day) to Day 90
Secondary outcomes (9)
Occurrence of Seroma
The investigator inspected each subject post surgery (Day 0) an each scheduled visit (Day 3, 7, 14, 28, 60, 90) to determine whether there were any areas on the abdominal wall that meet the definition of seroma. A seroma is a pocket of clear serous fluid that sometimes develops in the body after surgery. This fluid is composed of blood plasma that has seeped out of ruptured small blood vessels and inflammatory fluid produced by the injured and dying cells.
Measured: Day 0 (Surgery Day) to Day 90
Occurrence of Hematoma
The investigator inspected each subject post surgery (Day 0) an each scheduled visit (Day 3, 7, 14, 28, 60, 90) to determine whether there were any areas on the abdominal wall that meet the definition of hematoma. A hematoma is a collection of blood outside of a blood vessel.
Measured: Day 0 (Surgery Day) to Day 90
Time to Drain Removal
The drain was ready to be removed when the drainage volume in a given 24 hour period was <=30cc.
Measured: Day 0 (Surgery Day) up to Day 90
Number of Fluid Aspiration for Seromas
Number of interventions recorded.
Measured: Day 0 (Surgery Day) to Day 90
Total Volume of Fluid Aspirations for Seromas
Volume of fluid recovered was recorded.
Measured: Day 0 (Surgery Day) to Day 90
Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus
Test administered on abdomen midline using a set of different size Semmes-Weinstein monofilaments. These instruments are used to measure the cutaneous sensory perception threshold of patients. Each monofilament represents a unique amount of force. The force applied by each monofilament increases with each ascending size. Testing begins with small to large monofilaments. A higher score indicates a greater loss of sensation. Evaluator Size=ES, Hand \& Dorsal Foot Thresholds=HDFT, Normal=N, Diminished Light Touch=DLT,Diminished Protective Sensation=DPS, Loss of Protective Sensation=LOPS, Deep Pressure Sensation Only=DPSO:
ES=1.65 (minimum),HDFT=N;ES=2.36,HDFT=N;ES=2.44,HDFT=N;ES=2.83,HDFT=N;ES=3.22,HDFT=DLT;ES=3.61,HDFT=DLT;ES=3.84,HDFT=DPS;ES=4.08,HDFT=DPS;ES-4.17,HDFT=DPS;ES=4.31,HDFT=DPS;ES=4.56,HDFT=LOPS;ES=4.74,HDFT=LOPS;ES=4.93,HDFT=LOPS;ES=5.07,HDFT=LOPS;ES=5.18,HDFT=LOPS;ES=5.46,HDFT=LOPS;ES=5.88,HDFT=LOPS;ES=6.10,HDFT=LOPS;ES=6.45,HDFT=LOPS;ES=6.65 (maximum),HDFT=DPSO.
Measured: Days 0 (Baseline), 3, 7, 14, 28, 60, 90
Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus
Test administered on abdomen midline using a set of different size Semmes-Weinstein monofilaments. These instruments are used to measure the cutaneous sensory perception threshold of patients. Each monofilament represents a unique amount of force. The force applied by each monofilament increases with each ascending size. Testing begins with small to large monofilaments, pressing at a 90 degree angle for approximately 1.5 seconds against the skin until it bows then it is removed. The patient is instructed to respond when a stimuli is felt, and a score is applied based on the monofilament in use. A higher score indiactes a greater loss of sensation.
Measured: Days 0 (Baseline), 3, 7, 14, 28, 60, 90
Summary of Pain Assessment by Visit
Subjects were to be presented with a non-verbal visual analogue scale (VAS) to measure the level of pain (rating 0 [no pain] to 10 [worst possible pain]) the patient experienced at the site of surgery at the time of the visit.
Measured: Day 3, 7, 14, 28, 60, 90
Summary of Numbness Assessment by Visit
Subjects were to be presented with a non-verbal VAS to measure the level of numbness (rating 0 [no numbness] to 10 [complete numbness]) that the patient experienced at the time of the visit.
Measured: Day 3, 7, 14, 28, 60, 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2010
- Study completionFeb 2011
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 SeromaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve Z Abrams, MD, MBA, Study director, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112735
- Sponsor's protocol ID
- 550902
- Status last verified
- Jun 2018
- First submitted
- 27 Apr 2010
- Last updated
- 6 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of ARTISS (FS VH S/D 4 S-apr) for Flap Adherence in Subjects Undergoing Abdominoplasty
- ClinicalTrials.gov ID
- NCT01112735
- Acronym / sponsor ID
- 550902
- Keywords
- Abdominoplasty, Flap adherence in subjects undergoing abdominoplasty to eliminate dead space and reduce seroma/hematoma formation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 28 Apr 2010 (estimated)
- Results
- Posted 6 Jul 2018
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 ARTISS versus standard of care in adhering tissue places and reducing seroma/hematoma formation in subjects undergoing abdominoplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARTISS | Experimental | Biological: FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma)ARTISS will be used as an adjuvant to standard of care. |
| Standard of care | Other | Procedure: Standard of careStandard of care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is 18 to 75 years of age at the time of screening
- Subject is planned for primary standard abdominoplasty (status post Cesarean section or liposuction performed more than 6 months prior to enrollment in the study are allowed)
- If the subject is of childbearing potential; presents with a negative pregnancy test, and agrees to employ adequate birth control measures for the duration of the study
- Subject resides within 100 miles of the investigational site and is willing and able to comply with the scheduling requirements of the protocol (notably home visits by study personnel)
- Subject is willing and able to comply with the requirements of the protocol
Key exclusion criteria (23 listed)
- Subject is obese (body mass index [BMI] > 30 before surgery)
- Subject has experienced massive weight loss (subject has a history of obesity during adult life; subject lost more than 20 BMI unit score, subject has undergone a bariatric surgery)
- Subject has a history of active smoking within the previous 12 months
- Subject is elected for a non-standard abdominoplasty (extended, limited or mini-abdominoplasty, endoscopic, fleur-de-lis or circumferential abdominoplasty) or panniculectomy
- Subject has scars on the abdominal wall above the umbilicus. Vertical midline, laparoscopic punctures, or liposuction punctures are permitted
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-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma)Also: ARTISSDosage form: spray (aerosolized sealant), Dosage frequency: once (1 layer). ARTISS will be applied onto the fascia or the wound bed. | Biological | ARTISS |
| Standard of careStandard of care | Procedure or surgery | Standard of care |
Primary outcome
Total Drainage Volume Collected Until Drain Removal
Time frame: Day 0 (Surgery Day) to Day 90
Drainage fluids were to be collected through the Blake drain and into the collection bulb. The drainage volume was measured and recorded daily until the removal of the drain. During scheduled visits, measurement was to be performed at the study site, and on non-visit day recording of the drainage volume was to be done by a visiting home care nurse (or other study personnel). The drain was ready to be removed when the drainage volume in a given 24 hour period was <=30 cc.
9 secondary outcomes
Occurrence of Seroma
Time frame: Day 0 (Surgery Day) to Day 90
Occurrence of Hematoma
Time frame: Day 0 (Surgery Day) to Day 90
Time to Drain Removal
Time frame: Day 0 (Surgery Day) up to Day 90
Number of Fluid Aspiration for Seromas
Time frame: Day 0 (Surgery Day) to Day 90
Total Volume of Fluid Aspirations for Seromas
Time frame: Day 0 (Surgery Day) to Day 90
Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus
Time frame: Days 0 (Baseline), 3, 7, 14, 28, 60, 90
Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus
Time frame: Days 0 (Baseline), 3, 7, 14, 28, 60, 90
Summary of Pain Assessment by Visit
Time frame: Day 3, 7, 14, 28, 60, 90
Summary of Numbness Assessment by Visit
Time frame: Day 3, 7, 14, 28, 60, 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, MBA 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 2 study testing FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma) in people with Seroma and Hematoma, 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 5 inclusion and 23 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 6 Jul 2018. 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 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 6 Jul 2018). 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 Drainage Volume Collected Until Drain Removal (time frame: Day 0 (Surgery Day) to Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2018.