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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT00157131

Public ClinicalTrials.gov record NCT00157131. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 9:40 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00157131
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Baxter Healthcare Corporation
Industry
Enrollment
150 participants

Conditions and interventions

Interventions

Biological · Other

Eligibility (public fields only)

Age range
Up to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2004
Primary completion
Jan 31, 2007
Completion
Jan 31, 2007
Last update posted
Apr 19, 2017

2004 – 2007

United States locations

U.S. sites
17
U.S. states
12
U.S. cities
17
Facility City State ZIP Site status
Not listed Birmingham Alabama
Not listed Mobile Alabama
Not listed Phoenix Arizona
Not listed Orange California
Not listed Sacramento California
Not listed San Diego California
Not listed Gainesville Florida
Not listed Maywood Illinois
Not listed Springfield Illinois
Not listed Baltimore Maryland
Not listed Lincoln Nebraska
Not listed Cincinnati Ohio
Not listed Allentown Pennsylvania
Not listed Philadelphia Pennsylvania
Not listed Lubbock Texas
Not listed Seattle Washington
Not listed Madison Wisconsin

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00157131, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 19, 2017 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00157131 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →