NCT00735579

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 14, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2008

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2017

Completed
Last Updated

April 24, 2017

Status Verified

April 1, 2017

Enrollment Period

8.8 years

First QC Date

August 14, 2008

Last Update Submit

April 21, 2017

Conditions

Impaired Wound HealingFactor XIII Deficiency

Keywords

major abdominal surgerycoagulationextracellular matrix proteinswound healing after major abdominal surgery

Outcome Measures

Primary Outcomes (1)

  • Incidence of wound healing abnormalities

    Occurence of wound healing abnormalities within the first 28 days after surgery

    from baseline to postoperative day 28

Secondary Outcomes (1)

  • Abnormalities in coagulation parameters

    postoperative day 28

Study Arms (1)

Study group

Patients undergoing major abdominal surgery

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing major abdominal surgery

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum St. Georg gGmbH

Leipzig, Saxony, 04105, Germany

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

1\) serum samples for measurement of coagulation factors

MeSH Terms

Conditions

Factor XIII DeficiencyThrombosis

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Armin R Sablotzki, MD

    Klinikum St. Georg gGmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

August 14, 2008

First Posted

August 15, 2008

Study Start

July 1, 2008

Primary Completion

April 21, 2017

Study Completion

April 21, 2017

Last Updated

April 24, 2017

Record last verified: 2017-04

Locations

DE(1)