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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Deep Partial or Full Thickness Wounds

Intervention / Treatment
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* Biological: Fibrin Sealant, ARTISS 4IU/ml VH SD
* Other: Staples


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FS 4IU VH S/D<br>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. | Biological: Fibrin Sealant, ARTISS 4IU/ml VH SD<br>* 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.<br>|
| Active Comparator: Staples<br>Staples are the current standard of care in burn surgery and are well accepted as the control in this type of study. | Other: Staples<br>* Administration by mechanical/multiple point fixation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 28 days after treatment | 
| Adverse experiences (AEs) deemed possibly or probably related to treatment with FS 4IU VH S/D |  | 12 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of hematoma/seroma on Day 1 |  | 1 day after treatment | 
| Percent area of hematoma/seroma on Day 1 |  | 1 day after treatment | 
| 100% engraftment by Day 5 |  | 5 days after treatment | 
| Percent area of engraftment on Day 5 |  | 5 days after treatment | 
| Complete wound closure by Day 14 |  | 14 days after treatment | 
| Percent area of closure by Days 14 and 28 |  | 14 and 28 days after treatment | 
| Scar maturation assessed by blinded Vancouver Scar Scale evaluations on Months 3, 6, 9, and 12 |  | 3, 6, 9, and 12 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autologous sheet skin grafts, FS 4IU VH S/D, skin grafts, burn