Wound Healing Abnormalities in Major Abdominal Surgery (INWOUND)

This study is currently recruiting participants.
Verified July 2013 by Klinikum St. Georg gGmbH
Sponsor:
Collaborator:
Martin-Luther-Universität Halle-Wittenberg
Information provided by (Responsible Party):
Armin Sablotzki, MD, Klinikum St. Georg gGmbH
ClinicalTrials.gov Identifier:
NCT00735579
First received: August 14, 2008
Last updated: July 12, 2013
Last verified: July 2013
  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 or expression of extracellular matrix proteins.


Condition
Wound Healing
Abdominal Surgery

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 and Extracellular Matrix

Further study details as provided by Klinikum St. Georg gGmbH:

Primary Outcome Measures:
  • Incidence of wound healing abnormalities [ Time Frame: from baseline to postoperative day 28 ] [ Designated as safety issue: No ]
    Occurence of wound healing abnormalities within the first 28 days after surgery


Secondary Outcome Measures:
  • Abnormalities in coagulation parameters [ Time Frame: postoperative day 28 ] [ Designated as safety issue: No ]
    occurence of low platelets (<60.000) or factor XIII < 50% between the first and seventh postoperative day

  • Expression of extracellular matrix proteins [ Time Frame: postoperative day 28 ] [ Designated as safety issue: No ]
    changes in plasma levels of extracellular matrix protein between the first and seventh postoperative day


Biospecimen Retention:   Samples Without DNA
  1. whole blood samples for characterization of extracellular matrix proteins
  2. serum samples for measurement of coagulation factors

Estimated Enrollment: 200
Study Start Date: July 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study group
Patients undergoing major abdominal surgery

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735579

Contacts
Contact: Armin R Sablotzki, MD 0049-341-9092570 armin.sablotzki@sanktgeorg.de
Contact: Elke G Czeslick, MD 0049-341-9092570 elke.czeslick@sanktgeorg.de

Locations
Germany
Klinikum St. Georg gGmbH Recruiting
Leipzig, Sachsen, Germany, 04105
Contact: Armin R Sablotzki, MD    0049-3419092570    armin.sablotzki@sanktgeorg.de   
Sub-Investigator: Ralf Kleczewski, MD         
Sponsors and Collaborators
Klinikum St. Georg gGmbH
Martin-Luther-Universität Halle-Wittenberg
Investigators
Principal Investigator: Armin R Sablotzki, MD Klinikum St. Georg gGmbH
  More Information

Additional Information:
No publications provided

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
Study First Received: August 14, 2008
Last Updated: July 12, 2013
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on April 15, 2014