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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

Primary Purpose

Deep Partial or Full Thickness Wounds

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Fibrin Sealant, ARTISS 4IU/ml VH SD
Staples
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Partial or Full Thickness Wounds focused on measuring autologous sheet skin grafts, FS 4IU VH S/D, skin grafts, burn

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FS 4IU VH S/D

Staples

Arm Description

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.

Staples are the current standard of care in burn surgery and are well accepted as the control in this type of study.

Outcomes

Primary Outcome Measures

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
Adverse experiences (AEs) deemed possibly or probably related to treatment with FS 4IU VH S/D

Secondary Outcome Measures

Presence of hematoma/seroma on Day 1
Percent area of hematoma/seroma on Day 1
100% engraftment by Day 5
Percent area of engraftment on Day 5
Complete wound closure by Day 14
Percent area of closure by Days 14 and 28
Scar maturation assessed by blinded Vancouver Scar Scale evaluations on Months 3, 6, 9, and 12

Full Information

First Posted
September 8, 2005
Last Updated
April 19, 2017
Sponsor
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00157131
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Baxter Healthcare Corporation

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Partial or Full Thickness Wounds
Keywords
autologous sheet skin grafts, FS 4IU VH S/D, skin grafts, burn

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FS 4IU VH S/D
Arm Type
Experimental
Arm Description
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.
Arm Title
Staples
Arm Type
Active Comparator
Arm Description
Staples are the current standard of care in burn surgery and are well accepted as the control in this type of study.
Intervention Type
Biological
Intervention Name(s)
Fibrin Sealant, ARTISS 4IU/ml VH SD
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Staples
Intervention Description
Administration by mechanical/multiple point fixation.
Primary Outcome Measure Information:
Title
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
Title
Adverse experiences (AEs) deemed possibly or probably related to treatment with FS 4IU VH S/D
Time Frame
12 months after treatment
Secondary Outcome Measure Information:
Title
Presence of hematoma/seroma on Day 1
Time Frame
1 day after treatment
Title
Percent area of hematoma/seroma on Day 1
Time Frame
1 day after treatment
Title
100% engraftment by Day 5
Time Frame
5 days after treatment
Title
Percent area of engraftment on Day 5
Time Frame
5 days after treatment
Title
Complete wound closure by Day 14
Time Frame
14 days after treatment
Title
Percent area of closure by Days 14 and 28
Time Frame
14 and 28 days after treatment
Title
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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Greenhalgh, MD
Organizational Affiliation
Shriners Hospitals for Children, Northern Calif.
Official's Role
Principal Investigator
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Mobile
State/Province
Alabama
Country
United States
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Phoenix
State/Province
Arizona
Country
United States
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Orange
State/Province
California
Country
United States
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Sacramento
State/Province
California
Country
United States
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San Diego
State/Province
California
Country
United States
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Gainesville
State/Province
Florida
Country
United States
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Maywood
State/Province
Illinois
Country
United States
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Springfield
State/Province
Illinois
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United States
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Baltimore
State/Province
Maryland
Country
United States
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Lincoln
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Nebraska
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United States
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Cincinnati
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Ohio
Country
United States
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Allentown
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Pennsylvania
Country
United States
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Philadelphia
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Pennsylvania
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United States
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Lubbock
State/Province
Texas
Country
United States
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Seattle
State/Province
Washington
Country
United States
City
Madison
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18354285
Citation
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.
Results Reference
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Learn more about this trial

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

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