NCT00157131

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2004

Typical duration for phase_3

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

2.7 years

First QC Date

September 8, 2005

Last Update Submit

April 19, 2017

Conditions

Deep Partial or Full Thickness Wounds

Keywords

autologous sheet skin graftsFS 4IU VH S/Dskin graftsburn

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

FS 4IU VH S/D

EXPERIMENTAL

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

Staples

ACTIVE COMPARATOR

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

Other: Staples

Interventions

Fibrin Sealant, ARTISS 4IU/ml VH SDBIOLOGICAL

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.

FS 4IU VH S/D
StaplesOTHER

Administration by mechanical/multiple point fixation.

Staples

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Mobile, Alabama, United States

Location

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Orange, California, United States

Location

Unknown Facility

Sacramento, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Gainesville, Florida, United States

Location

Unknown Facility

Maywood, Illinois, United States

Location

Unknown Facility

Springfield, Illinois, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Lincoln, Nebraska, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Allentown, Pennsylvania, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Lubbock, Texas, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

Unknown Facility

Madison, Wisconsin, United States

Location

Related Publications (1)

  • 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.

    PMID: 18354285RESULT

MeSH Terms

Conditions

Burns

Interventions

Fibrin Tissue AdhesiveSutures

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSurgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • David Greenhalgh, MD

    Shriners Hospitals for Children, Northern Calif.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

June 1, 2004

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

April 20, 2017

Record last verified: 2017-04

Locations

US(17)