Wound Healing Abnormalities in Major Abdominal Surgery (INWOUND)

April 21, 2017 updated by: Armin Sablotzki, MD, Klinikum St. Georg gGmbH

Incidence of Wound-healing-abnormalities in Major Abdominal Surgery - Association With Factors of Coagulation

This clinical observational study investigates the incidence of wound healing abnormalities in patients undergoing major abdominal surgery. Second aim of the study is, if wound healing deficits may be accompanied by abnormalities in blood coagulation parameters.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Sachsen
      • Leipzig, Sachsen, Germany, 04105
        • Klinikum St. Georg gGmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients undergoing major abdominal surgery

Description

Inclusion Criteria:

  • Age >= 18 years
  • Male or female
  • Informed consent
  • Major abdominal surgery

Exclusion Criteria:

  • Pre-existing coagulation abnormalities
  • Pre-existing severe renal or liver failure
  • Chemo- or radiochemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Study group
Patients undergoing major abdominal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of wound healing abnormalities
Time Frame: from baseline to postoperative day 28
Occurence of wound healing abnormalities within the first 28 days after surgery
from baseline to postoperative day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abnormalities in coagulation parameters
Time Frame: postoperative day 28
occurence of low platelets (<60.000) or factor XIII < 50% between the first and seventh postoperative day
postoperative day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinikum St. Georg gGmbH

Investigators

  • Principal Investigator: Armin R Sablotzki, MD, Klinikum St. Georg gGmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

April 21, 2017

Study Completion (Actual)

April 21, 2017

Study Registration Dates

First Submitted

August 14, 2008

First Submitted That Met QC Criteria

August 14, 2008

First Posted (Estimate)

August 15, 2008

Study Record Updates

Last Update Posted (Actual)

April 24, 2017

Last Update Submitted That Met QC Criteria

April 21, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK-BR-21/08-1
  • Stu08/0022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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