Safety and Efficacy Study of FS 4 IU VH S/D (Fibrin Sealant With 4IU/mL Thrombin, Vapor Heated, S… (NCT00157131) | Clinical Trial Compass
CompletedPhase 3
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
United States150 participantsStarted 2004-06
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: 28 days after treatment
2
Adverse experiences (AEs) deemed possibly or probably related to treatment with FS 4IU VH S/D