BurnsPhase 1/2NCT00161759
Safety and Efficacy Study of Fibrin Sealant (FS 4IU) for Skin Graft Fixation and Wound Healing in Subjects With Burn Wounds
A Phase 1/2 study testing Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin in people with Burns, run by Baxter Healthcare Corporation at 12 sites in United States.
Trial summary
The purpose of this study is to assess if Fibrin Sealant 4IU is as safe and efficacious as staples (the current standard of care) to achieve fixation of skin grafts and wound healing in subjects with burn wounds. Each subject receives staples as well as FS 4IU on comparable treatment sites. Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- Burns
- What is being tested?
- Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin
- How many people
- 40 participants
- Where
- 12 sitesUnited States
- Study dates
- Mar 2002to Jan 2004
- Phase
- Phase 1/2
- 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 6 to 65 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to screening activities
- Male or female age >= 6 and <= 65 years of age
- Total burn wounds measuring <= 40% TBSA to include a deep partial thickness/full thickness area requiring autologous split thickness sheet skin grafts
- The selected test area consisting of a contiguous, deep partial thickness/full thickness burn wound between 2% and 8% TBSA, which can be divided into two approximate halves or two bilateral wounds (each measuring between 1% and 4% TBSA)
- Females of child-bearing potential with a negative urine or serum pregnancy test on admission
- Able and willing to comply with the procedures required by the protocol
Who cannot join
- Conductive electrical burns and chemical burns
- Digits, head, genitalia, palms of hands, soles of feet, and face are excluded as test sites
- Circumferential burns are excluded as a test area
- 4th or 5th degree burns
- Test area with infection as determined clinically by the Investigator prior to surgery
- Venous or arterial vascular disorder directly affecting a designated test area
Show all 14Show fewer
- Known immune deficiency disorder, either congenital or acquired
- Chronically malnourished as determined clinically by the investigator prior to surgery (Investigators are responsible for determining subjects are chronically malnourished during the screening process. Investigators should take into consideration the following parameters: Medical history and physical appearance, the subject's body mass index, and any significant laboratory findings)
- Severe respiratory problems or concurrent head trauma at hospital admission
- Any chronic condition requiring the use of systemic corticosteroids 30 days prior to study entry and anytime during the course of the study
- Known or newly diagnosed diabetics requiring insulin
- Any other acute or chronic concurrent medical condition(s) that in the Investigator's opinion are a contraindication to skin grafting and study participation
- Known or suspected hypersensitivity to bovine protein
- Concurrent participation in another clinical trial in which an investigational agent is used. (Subjects must not have been enrolled in another clinical trial within 30 days of enrolling in this trial).
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Joseph M. Still Burn Center at Doctors Hospital
Augusta, Georgia, 30909
Bridgeport Hospital
Bridgeport, Connecticut, 06610
Shriners Hospitals for Children
Cincinnati, Ohio, 45229
Wright State University, Miami Valley Hospital
Dayton, Ohio, 45409-2722
Shriners Hospitals for Children, Galveston
Galveston, Texas, 77550-2725
Loyola University Medical Center
Maywood, Illinois, 60153
University of South Alabama Medical Center
Mobile, Alabama, 36617
UCI Medical Center
Orange, California, 92868-3298
Maricopa Medical Center
Phoenix, Arizona, 85008
University of California Davis Medical Center; Shriners Hospitals for Children
Sacramento, California, 95817
UCSD Medical Center
San Diego, California, 92103-8896
University of Washington Burn Center
Seattle, Washington, 98104
About this study
Official title: A Study to Assess the Safety and Efficacy of Fibrin Sealant (FS 4IU) for Wound Healing in Subjects With Burn Wounds Requiring Skin Grafting Procedures
The purpose of this study is to assess if Fibrin Sealant 4IU is as safe and efficacious as staples (the current standard of care) to achieve fixation of skin grafts and wound healing in subjects with burn wounds. Each subject receives staples as well as FS 4IU on comparable treatment sites.
- Conditions
- Burns
- Being tested
- Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL ThrombinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startMar 2002
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David G. Greenhalgh, MD, Principal investigator, University of California Davis Medical Center, Sacramento; Shriners Hospitals for Children, Sacramento, CAMarianne Cinat, MD, Principal investigator, University of California Irvine, Orange, CAArnold Luterman, MD, Principal investigator, University of South Alabama Medical Center, Mobile, ALNicole Gibran, MD, Principal investigator, University of Washington Burn Center, Seattle, WAGlenn D. Warden, MD, Principal investigator, Shriners Hospitals for Children, Cincinnati, OHDavid Herndon, MD, Principal investigator, Shriners Hospitals for Children, Galveston, TXRichard L. Gamelli, MD, Principal investigator, Loyola University Medical Center, Maywood, ILSidney F. Miller, MD, Principal investigator, Wright State University, Miami Valley Hospital, Dayton, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161759
- Sponsor's protocol ID
- 520001
- Status last verified
- Oct 2006
- First submitted
- 8 Sep 2005
- Last updated
- 20 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Safety and Efficacy of Fibrin Sealant (FS 4IU) for Wound Healing in Subjects With Burn Wounds Requiring Skin Grafting Procedures
- ClinicalTrials.gov ID
- NCT00161759
- Acronym / sponsor ID
- 520001
- Conditions
- Burns
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Study completion
- Jan 2004
- First posted
- 13 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 purpose of this study is to assess if Fibrin Sealant 4IU is as safe and efficacious as staples (the current standard of care) to achieve fixation of skin grafts and wound healing in subjects with burn wounds. Each subject receives staples as well as FS 4IU on comparable treatment sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to screening activities
- Male or female age >= 6 and <= 65 years of age
- Total burn wounds measuring <= 40% TBSA to include a deep partial thickness/full thickness area requiring autologous split thickness sheet skin grafts
- The selected test area consisting of a contiguous, deep partial thickness/full thickness burn wound between 2% and 8% TBSA, which can be divided into two approximate halves or two bilateral wounds (each measuring between 1% and 4% TBSA)
- Females of child-bearing potential with a negative urine or serum pregnancy test on admission
Key exclusion criteria (14 listed)
- Conductive electrical burns and chemical burns
- Digits, head, genitalia, palms of hands, soles of feet, and face are excluded as test sites
- Circumferential burns are excluded as a test area
- 4th or 5th degree burns
- Test area with infection as determined clinically by the Investigator prior to surgery
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 |
|---|---|---|
| Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin | Drug | – |
Primary outcome
Not reported in the source record.
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 Oct 2006.
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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.
David G. Greenhalgh, MD principal investigator
University of California Davis Medical Center, Sacramento; Shriners Hospitals for Children, Sacramento, CA
Marianne Cinat, MD principal investigator
University of California Irvine, Orange, CA
Arnold Luterman, MD principal investigator
University of South Alabama Medical Center, Mobile, AL
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin in people with Burns, run by Baxter Healthcare Corporation at 12 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 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 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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.
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 20 Oct 2006.