Clinical trial NCT00157131: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Deep Partial or Full Thickness Wounds
Keywords: autologous sheet skin grafts
FS 4IU VH S/D
skin grafts
burn
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 150
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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
measure: Adverse experiences (AEs) deemed possibly or probably related to treatment with FS 4IU VH S/D
timeFrame: 12 months after treatment
Secondary outcomes:
measure: Presence of hematoma/seroma on Day 1
timeFrame: 1 day after treatment
measure: Percent area of hematoma/seroma on Day 1
timeFrame: 1 day after treatment
measure: 100% engraftment by Day 5
timeFrame: 5 days after treatment
measure: Percent area of engraftment on Day 5
timeFrame: 5 days after treatment
measure: Complete wound closure by Day 14
timeFrame: 14 days after treatment
measure: Percent area of closure by Days 14 and 28
timeFrame: 14 and 28 days after treatment
measure: Scar maturation assessed by blinded Vancouver Scar Scale evaluations on Months 3, 6, 9, and 12
timeFrame: 3, 6, 9, and 12 months after treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Orange
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Gainesville
country: United States
state: Florida
city: Maywood
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: Lincoln
country: United States
state: Nebraska
city: Cincinnati
country: United States
state: Ohio
city: Allentown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Lubbock
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Shriners Hospitals for Children, Northern Calif.
name: David Greenhalgh, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.