NCT00181974

Brief Summary

The purpose of this study is to determine the effectiveness of a fibrin glue in burn surgery with respect to hemostasis and skin graft fixation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2000

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

October 24, 2012

Status Verified

October 1, 2012

Enrollment Period

6.9 years

First QC Date

September 14, 2005

Last Update Submit

October 22, 2012

Conditions

Burns

Keywords

burnshemostasisskin graftSurgical HemostasisGrafting, Skin

Outcome Measures

Primary Outcomes (5)

  • initial wound hemostasis

  • initial donor site hemostasis

  • initial graft fixation

  • percent graft take at 1 week

  • outcome and cosmetic appearance at routine intervals up to 24 months

Interventions

Tisseel Fibrin SealantDRUG

Eligibility Criteria

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

You may qualify if:

  • Requires skin grafting of an acute or reconstructive burn wound.

You may not qualify if:

  • Active disseminated intravascular coagulation (DIC) or known hypersensitivity to bovine protein.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shriners Burns Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Robert L Sheridan, M.D.

    Shriners Burns Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgeon

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 16, 2005

Study Start

March 1, 2000

Primary Completion

February 1, 2007

Study Completion

November 1, 2007

Last Updated

October 24, 2012

Record last verified: 2012-10

Locations

US(1)