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

NCT ID: NCT00157131

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2007-02-28

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.

Conditions

Deep Partial or Full Thickness Wounds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

FS 4IU VH S/D

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.

Group Type: EXPERIMENTAL

Fibrin Sealant, ARTISS 4IU/ml VH SD

Intervention Type: BIOLOGICAL

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.

Staples

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

Group Type: ACTIVE_COMPARATOR

Staples

Intervention Type: OTHER

Administration by mechanical/multiple point fixation.

Interventions

Fibrin Sealant, ARTISS 4IU/ml VH SD

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: BIOLOGICAL

Staples

Administration by mechanical/multiple point fixation.

Intervention Type: OTHER

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.

• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: lead

Principal Investigators

David Greenhalgh, MD

Role: PRINCIPAL_INVESTIGATOR

Shriners Hospitals for Children, Northern Calif.

Locations

Birmingham, Alabama, United States

Mobile, Alabama, United States

Phoenix, Arizona, United States

Orange, California, United States

Sacramento, California, United States

San Diego, California, United States

Gainesville, Florida, United States

Maywood, Illinois, United States

Springfield, Illinois, United States

Baltimore, Maryland, United States

Lincoln, Nebraska, United States

Cincinnati, Ohio, United States

Allentown, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Lubbock, Texas, United States

Seattle, Washington, United States

Madison, Wisconsin, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 18354285 (View on PubMed)

Other Identifiers

550201

Identifier Type: -

Identifier Source: org_study_id