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NCT00735579 Clinical Trial

Wound Healing Abnormalities in Major Abdominal Surgery

Impaired Wound Healing Clinical Trial

— INWOUND  

Official title:
Incidence of Wound-healing-abnormalities in Major Abdominal Surgery - Association With Factors of Coagulation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00735579
Other study ID # EK-BR-21/08-1
Secondary ID Stu08/0022
Status Completed
Phase N/A
First received August 14, 2008
Last updated April 21, 2017
Start date July 2008
Est. completion date April 21, 2017

Study information
Verified date April 2017
Source Klinikum St. Georg gGmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 260
Est. completion date April 21, 2017
Est. primary completion date April 21, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Klinikum St. Georg gGmbH Leipzig Sachsen

Sponsors (1)
Lead Sponsor Collaborator
Klinikum St. Georg gGmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of wound healing abnormalities Occurence of wound healing abnormalities within the first 28 days after surgery from baseline to postoperative day 28
Secondary Abnormalities in coagulation parameters occurence of low platelets (<60.000) or factor XIII < 50% between the first and seventh postoperative day postoperative day 28
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Not yet recruiting NCT01002521 - Wound Healing In Diabetes (WHy) Study N/A
Completed NCT01539980 - Clinical Study on Silk Sericin Wound Dressing for Split-thickness Skin Graft Donor Sites Treatment Phase 1/Phase 2
Completed NCT01528033 - Treatment Study of Vacuum Assisted Closure for Postsurgical Subcutaneous Abdominal Wound Healing Impairments N/A
Completed NCT00651820 - Effect of Collagenase on Healing and Scarring Phase 4

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