Deep Partial or Full Thickness WoundsPhase 3NCT00157131
Safety and Efficacy Study of FS 4 IU VH S/D (Fibrin Sealant With 4IU/mL Thrombin, Vapor Heated, Solvent/Detergent Treated) to Adhere Split Thickness Skin Grafts and Improve Wound Healing in Burn Patients
A Phase 3 study testing Fibrin Sealant, ARTISS 4IU/ml VH SD and Staples in people with Deep Partial or Full Thickness Wounds, run by Baxter Healthcare Corporation at 17 sites in United States.
Trial summary
The primary objective of this study is to evaluate skin graft adherence and wound healing in burn patients to evaluate whether FS 4IU VH S/D is equivalent or superior to the current standard of care (staples). The primary endpoint is achievement of complete (100%) wound closure within 28 days. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Deep Partial or Full Thickness Wounds
- What is being tested?
- Fibrin Sealant, ARTISS 4IU/ml VH SD and Staples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 17 sitesUnited States
- Study dates
- Jun 2004to Feb 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects or their legal representatives, who have read, understood and signed a written informed consent.
- Subjects of either sex.
- Female subjects of childbearing potential with a negative urine or serum pregnancy test on admission.
- Subjects who are <= 65 years of age including pediatric subjects of all ages.
- Subjects with total burn wounds measuring <= 40% TBSA.
- Subjects with a contiguous deep partial thickness/full thickness wound, between 2% and 8% TBSA or two comparable, bilateral wounds each measuring between 1% and 4% TBSA.
- Wounds designated as test sites require autologous sheet skin grafts with a thickness of 8/1000" - 16/1000"
- Subjects who are able, and willing to comply with the procedures required by the protocol.
Who cannot join
- Subjects with electrical burns.
- Subjects with chemical burns
- Digits and genitalia are excluded as test sites.
- Subjects with infection at test area/test sites.
- Subjects with test sites previously randomized and treated in this study.
- Subjects with venous or arterial vascular disorder that directly affects a designated test area/test site.
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- Subjects with pre-existing hemolytic anemia
- Subjects with diabetes mellitus.
- Subjects with documented history of pathologically or pharmacologically induced immune deficiency.
- Subjects judged to be chronically malnourished.
- Subjects that are judged to have significant pulmonary compromise.
- Subjects receiving systemic corticosteroids within 30 days prior to skin grafting (not including inhaled steroids).
- Subjects with known or suspected hypersensitivity to bovine proteins.
- Subjects participating in another clinical trial that is evaluating an unapproved drug or device.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Study site
Allentown, Pennsylvania
Study site
Baltimore, Maryland
Study site
Birmingham, Alabama
Study site
Cincinnati, Ohio
Study site
Gainesville, Florida
Study site
Lincoln, Nebraska
Study site
Lubbock, Texas
Study site
Madison, Wisconsin
Study site
Maywood, Illinois
Study site
Mobile, Alabama
Study site
Orange, California
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Sacramento, California
Study site
San Diego, California
Study site
Seattle, Washington
Study site
Springfield, Illinois
About this study
Official title: A Study To Evaluate the Safety and Efficacy of Fibrin Sealant With 4IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated (FS 4IU VH S/D) to Adhere Tissues and Improve Wound Healing
The primary objective of this study is to evaluate skin graft adherence and wound healing in burn patients to evaluate whether FS 4IU VH S/D is equivalent or superior to the current standard of care (staples). The primary endpoint is achievement of complete (100%) wound closure within 28 days.
- Conditions
- Deep Partial or Full Thickness Wounds
- Being tested
- Fibrin Sealant, ARTISS 4IU/ml VH SD, Staples
- Keywords
- autologous sheet skin grafts, FS 4IU VH S/D, skin grafts, burn
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin Sealant, ARTISS 4IU/ml VH SDBiological
FS 4IU VH S/D, a two-component fibrin sealant with 4 IU/mL human thrombin, vapor heated, solvent detergent treated, provided in a frozen, ready-to-use formulation. Administration by a topical spray application using the TISSOMAT device and Spray Set.
StaplesOther
Administration by mechanical/multiple point fixation.
| Study group | Role | What they receive |
|---|---|---|
| FS 4IU VH S/D | Experimental | FS 4IU VH S/D was administered intraoperatively to the wound bed by spray application using the TISSOMAT and Spray Set. Only the DUPLOJECTvii system and Spray Set (connection tube with sterile filter and spray head) device was used for simultaneous spray application of the study product. A thin layer of FS 4IU VH S/D was applied to the wound bed using a "painting motion" from side to side to achieve coverage. The recommended dosing volume was 2.0 to 4.0 mL/100 cm2. One 2-mL pack (4 mL total volume) of FS 4IU VH S/D applied using the TISSOMAT and Spray Set was sufficient to coat a wound bed of 100-200 cm2. Receives: Biological: Fibrin Sealant, ARTISS 4IU/ml VH SD |
| Staples | Active comparator | Staples are the current standard of care in burn surgery and are well accepted as the control in this type of study. Receives: Other: Staples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete wound closure by Day 28 after treatment with either FS 4IU VH S/D or staples as determined by a blinded independent review of the Day 28 photographs
Measured: 28 days after treatment
Adverse experiences (AEs) deemed possibly or probably related to treatment with FS 4IU VH S/D
Measured: 12 months after treatment
Secondary outcomes (7)
Presence of hematoma/seroma on Day 1
Measured: 1 day after treatment
Percent area of hematoma/seroma on Day 1
Measured: 1 day after treatment
100% engraftment by Day 5
Measured: 5 days after treatment
Percent area of engraftment on Day 5
Measured: 5 days after treatment
Complete wound closure by Day 14
Measured: 14 days after treatment
Percent area of closure by Days 14 and 28
Measured: 14 and 28 days after treatment
Scar maturation assessed by blinded Vancouver Scar Scale evaluations on Months 3, 6, 9, and 12
Measured: 3, 6, 9, and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep Partial or Full Thickness WoundsStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Greenhalgh, MD, Principal investigator, Shriners Hospitals for Children, Northern Calif.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157131
- Sponsor's protocol ID
- 550201
- Status last verified
- Apr 2017
- First submitted
- 8 Sep 2005
- Last updated
- 20 Apr 2017
- Results posted
- No
Publications
Foster K, Greenhalgh D, Gamelli RL, Mozingo D, Gibran N, Neumeister M, Abrams SZ, Hantak E, Grubbs L, Ploder B, Schofield N, Riina LH; FS 4IU VH S/D Clinical Study Group. Efficacy and safety of a fibrin sealant for adherence of autologous skin grafts to burn wounds: results of a phase 3 clinical study. J Burn Care Res. 2008 Mar-Apr;29(2):293-303. doi: 10.1097/BCR.0b013e31816673f8.
PubMed 18354285
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study To Evaluate the Safety and Efficacy of Fibrin Sealant With 4IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated (FS 4IU VH S/D) to Adhere Tissues and Improve Wound Healing
- ClinicalTrials.gov ID
- NCT00157131
- Acronym / sponsor ID
- 550201
- Conditions
- Deep Partial or Full Thickness Wounds
- Keywords
- autologous sheet skin grafts, FS 4IU VH S/D, skin grafts, burn
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate skin graft adherence and wound healing in burn patients to evaluate whether FS 4IU VH S/D is equivalent or superior to the current standard of care (staples). The primary endpoint is achievement of complete (100%) wound closure within 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FS 4IU VH S/D | Experimental | Biological: Fibrin Sealant, ARTISS 4IU/ml VH SDFS 4IU VH S/D was administered intraoperatively to the wound bed by spray application using the TISSOMAT and Spray Set. Only the DUPLOJECTvii system and Spray Set (connection tube with sterile filter and spray head) device was used for simultaneous spray application of the study product. A thin layer of FS 4IU VH S/D was applied to the wound bed using a "painting motion" from side to side to achieve coverage. The recommended dosing volume was 2.0 to 4.0 mL/100 cm2. One 2-mL pack (4 mL total volume) of FS 4IU VH S/D applied using the TISSOMAT and Spray Set was sufficient to coat a wound bed of 100-200 cm2. |
| Staples | Active comparator | Other: StaplesStaples are the current standard of care in burn surgery and are well accepted as the control in this type of study. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects or their legal representatives, who have read, understood and signed a written informed consent.
- Subjects of either sex.
- Female subjects of childbearing potential with a negative urine or serum pregnancy test on admission.
- Subjects who are <= 65 years of age including pediatric subjects of all ages.
- Subjects with total burn wounds measuring <= 40% TBSA.
Key exclusion criteria (14 listed)
- Subjects with electrical burns.
- Subjects with chemical burns
- Digits and genitalia are excluded as test sites.
- Subjects with infection at test area/test sites.
- Subjects with test sites previously randomized and treated in this study.
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 |
|---|---|---|
| Fibrin Sealant, ARTISS 4IU/ml VH SDFS 4IU VH S/D, a two-component fibrin sealant with 4 IU/mL human thrombin, vapor heated, solvent detergent treated, provided in a frozen, ready-to-use formulation. Administration by a topical spray application using the TISSOMAT device and Spray Set. | Biological | FS 4IU VH S/D |
| StaplesAdministration by mechanical/multiple point fixation. | Other | Staples |
Primary outcome
Complete wound closure by Day 28 after treatment with either FS 4IU VH S/D or staples as determined by a blinded independent review of the Day 28 photographs
Time frame: 28 days after treatment
Adverse experiences (AEs) deemed possibly or probably related to treatment with FS 4IU VH S/D
Time frame: 12 months after treatment
7 secondary outcomes
Presence of hematoma/seroma on Day 1
Time frame: 1 day after treatment
Percent area of hematoma/seroma on Day 1
Time frame: 1 day after treatment
100% engraftment by Day 5
Time frame: 5 days after treatment
Percent area of engraftment on Day 5
Time frame: 5 days after treatment
Complete wound closure by Day 14
Time frame: 14 days after treatment
Percent area of closure by Days 14 and 28
Time frame: 14 and 28 days after treatment
Scar maturation assessed by blinded Vancouver Scar Scale evaluations on Months 3, 6, 9, and 12
Time frame: 3, 6, 9, and 12 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Results publication: PubMed 18354285Foster K, Greenhalgh D, Gamelli RL, Mozingo D, Gibran N, Neumeister M, Abrams SZ, Hantak E, Grubbs L, Ploder B, Schofield N, Riina LH; FS 4IU VH S/D Clinical Study Group. Efficacy and safety of a fibrin sealant for adherence of autologous skin grafts to burn wounds: results of a phase 3 clinical study. J Burn Care Res. 2008 Mar-Apr;29(2):293-303. doi: 10.1097/BCR.0b013e31816673f8.
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.
David Greenhalgh, MD principal investigator
Shriners Hospitals for Children, Northern Calif.
17 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 Fibrin Sealant, ARTISS 4IU/ml VH SD and Staples in people with Deep Partial or Full Thickness Wounds, run by Baxter Healthcare Corporation at 17 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 8 inclusion and 14 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 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete wound closure by Day 28 after treatment with either FS 4IU VH S/D or staples as determined by a blinded independent review of the Day 28 photographs (time frame: 28 days after treatment). 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 NCT00157131, 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 20 Apr 2017.