Diagnostic of Infections Following Major Abdominal Surgery and Burn Injury

Second Degree Burn Clinical Trial

— Earlygnost  

Official title:

Impact of Biomarkers for Early Diagnostic of Infections Following Major Abdominal Surgery and Severe Burn Injuries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01055587
• Other study ID #: EK-BR-29/09-1
• Secondary ID: Stu09/0031
• Status: Completed
• Phase: N/A
• First received: January 22, 2010
• Last updated: February 7, 2017
• Start date: September 2009
• Est. completion date: June 2015

Study information

• Verified date: February 2017
• Source: Klinikum St. Georg gGmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study was designed to investigate, if new biomarkers may improve the early diagnostic of infections following major abdominal surgery and severe burn injuries.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with major abdominal surgery (e.g. gastrectomy, hemi-/colectomy, resection of sigma or rectum, resection of liver, esophagectomy)

• patients following severe burn injury (burn surface area >= 15%)

• age >= 18 years

• informed consent

Exclusion Criteria:

• no informed consent

• emergency surgery

• immunocompromising diseases (e.g. HIV+, AIDS, Lymphoma or NonHodgkin-Lymphoma, Autoimmune-Diseases)

• pre-existing liver or renal failure

• chronic therapy with corticoids

Related Conditions & MeSH terms

• Burns
• Infection
• Second Degree Burn
• Third Degree Burn

Locations

Country	Name	City	State
Germany	Klinikum St. Georg gGmbH	Leipzig	Sachsen

Sponsors (2)

Lead Sponsor	Collaborator
Klinikum St. Georg gGmbH	Martin-Luther-Universität Halle-Wittenberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of infections		day 28 post intervention