Wound Healing Abnormalities in Major Abdominal Surgery | NCT00735579

Studies
Wound Healing Abnormalities in Major Abdominal Surgery

NCT00735579

Sponsor

Klinikum St. Georg gGmbH

Status

Completed

Last Update Posted

Apr 24, 2017Actual

Enrollment

260Actual

Phase

Not provided

Conditions

Impaired Wound Healing
Factor XIII Deficiency

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Stu08/0022

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Apr 21, 2017Actual

Completion Date

Apr 21, 2017Actual

First Submitted Date

Aug 14, 2008

First Submission Date that Met QC Criteria

Aug 14, 2008

First Posted Date

Aug 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2017

Last Update Posted Date

Apr 24, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

260Actual

Label	Type	Description	Intervention Names
Study group		Patients undergoing major abdominal surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

patients undergoing major abdominal surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Armin R Sablotzki, MD	Klinikum St. Georg gGmbH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum St. Georg gGmbH		Leipzig	Saxony	04105	Germany

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D005177	Factor XIII Deficiency
D013927	Thrombosis

Ancestor Terms

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided