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Wound Healing Abnormalities in Major Abdominal Surgery (INWOUND)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00735579
First Posted: August 15, 2008
Last Update Posted: April 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Armin Sablotzki, MD, Klinikum St. Georg gGmbH
  Purpose
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.

Condition
Impaired Wound Healing Factor XIII Deficiency

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence of Wound-healing-abnormalities in Major Abdominal Surgery - Association With Factors of Coagulation

Resource links provided by NLM:


Further study details as provided by Armin Sablotzki, MD, Klinikum St. Georg gGmbH:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples Without DNA
1) serum samples for measurement of coagulation factors

Enrollment: 260
Study Start Date: July 2008
Study Completion Date: April 21, 2017
Primary Completion Date: April 21, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study group
Patients undergoing major abdominal surgery

  Eligibility

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients undergoing major abdominal surgery
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00735579


Locations
Germany
Klinikum St. Georg gGmbH
Leipzig, Sachsen, Germany, 04105
Sponsors and Collaborators
Klinikum St. Georg gGmbH
Investigators
Principal Investigator: Armin R Sablotzki, MD Klinikum St. Georg gGmbH
  More Information

Additional Information:
Responsible Party: Armin Sablotzki, MD, Prof. Dr. med., Klinikum St. Georg gGmbH
ClinicalTrials.gov Identifier: NCT00735579     History of Changes
Other Study ID Numbers: EK-BR-21/08-1
Stu08/0022
First Submitted: August 14, 2008
First Posted: August 15, 2008
Last Update Posted: April 24, 2017
Last Verified: April 2017

Keywords provided by Armin Sablotzki, MD, Klinikum St. Georg gGmbH:
major abdominal surgery
coagulation
extracellular matrix proteins
wound healing after major abdominal surgery

Additional relevant MeSH terms:
Wounds and Injuries
Factor XIII Deficiency
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn