Wound Healing Abnormalities in Major Abdominal Surgery (INWOUND)

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. Identifier: NCT00735579
Recruitment Status : Completed
First Posted : August 15, 2008
Last Update Posted : April 24, 2017
Information provided by (Responsible Party):
Armin Sablotzki, MD, Klinikum St. Georg gGmbH

Brief Summary:
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 or disease
Impaired Wound Healing Factor XIII Deficiency

Study Type : Observational
Actual Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence of Wound-healing-abnormalities in Major Abdominal Surgery - Association With Factors of Coagulation
Study Start Date : July 2008
Actual Primary Completion Date : April 21, 2017
Actual Study Completion Date : April 21, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Study group
Patients undergoing major abdominal surgery

Primary Outcome Measures :
  1. 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 :
  1. 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

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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

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

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 identifier (NCT number): NCT00735579

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

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

Keywords provided by Armin Sablotzki, MD, Klinikum St. Georg gGmbH:
major abdominal surgery
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