NCT00371215

Brief Summary

The purpose of this study is to evaluate whether rThrombin is safe when used for controlling bleeding during skin graft surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

March 9, 2009

Status Verified

March 1, 2009

Enrollment Period

10 months

First QC Date

August 30, 2006

Last Update Submit

March 6, 2009

Conditions

Surgical Hemostasis

Keywords

hemostasisgrafting, skinhemostaticsphase 2

Outcome Measures

Primary Outcomes (1)

  • The incidence and severity of adverse events

    Up to day 29

Secondary Outcomes (5)

  • The incidence and grade of clinical laboratory abnormalities

    Up to day 29

  • The incidence of anti-rThrombin product antibodies

    Up to day 29

  • The incidence of hemostasis

    Up to 20 minutes

  • The percentage of graft take

    Up to day 29

  • The incidence of re-grafting

    Up to day 29

Study Arms (1)

1

EXPERIMENTAL

rThrombin

Biological: rThrombin

Interventions

rThrombinBIOLOGICAL

1000 U/mL applied topically

1

Eligibility Criteria

Age2 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Autologous skin grafting with sheet or mesh grafts following burn or traumatic skin injury

You may not qualify if:

  • Known antibodies or hypersensitivity to thrombin or other coagulation factors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richard M. Fairbanks Burn Center, Wishard Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Interventions

recombinant human thrombin

Study Officials

  • Allan Alexander, MD

    ZymoGenetics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 30, 2006

First Posted

September 1, 2006

Study Start

August 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

March 9, 2009

Record last verified: 2009-03

Locations

US(1)