|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 December 2012 |
|
Main ID: |
NCT01181206 |
|
Date of registration:
|
11/08/2010 |
|
Primary sponsor: |
|
|
Public title:
|
Covering of the Abdominal Wall in Laparotomies: Differences in Surgical Site Infections Between an Approved Abdominal 3M™ Steri-Drape™ Wound Edge Protector and Standard Woven Swabs at Technische Universität München
BaFo |
|
Scientific title:
|
Standard-Bauchwandabdeckung Mit Bauchtüchern vs. Abdeckung Mittels ringförmiger Folie: Eine Doppelblinde Randomisiert-kontrollierte Studie |
|
Date of first enrolment:
|
August 2010 |
|
Target sample size:
|
516 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01181206 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Contacts
|
|
Name:
|
Helmut Friess, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Department of Surgery, Klinikum rechts der Isar der Technischen Universität München |
|
|
Name:
|
Joerg Kleeff, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Department of Surgery, Klinikum rechts der Isar der Technischen Universität München |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Ability to sign the informed consent
- Patients older than 18 years
- Abdominal operations with longitudinal / cross section with clean wounds,
clean-contaminated wounds or contaminated wounds (cdc-definitions of surgical wound
infections)
Exclusion Criteria:
- Pregnant or lactating women
- Revision Operations
- Operations with dirty or infected wounds (CDC definition of surgical wound
infections)
- Laparoscopic operations
- Small operations without longitudinal- / cross-section e.g. appendectomy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Comparing the Number of Surgical Site Infections:
|
|
Covering of the Abdominal Wall in Laparotomies With an Approved Abdominal 3M™ Steri-Drape™ Wound Edge Protector and Standard Woven
|
|
Swabs
|
|
Intervention(s)
|
|
Procedure: Intervention Arm 1: Covering with approved abdominal 3M™ Steri-Drape™ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs
|
|
Primary Outcome(s)
|
|
Surgical site infections
[Time Frame: 3 years]
|
|
Secondary Outcome(s)
|
|
Body-Temperature during Operation
[Time Frame: 3 years]
|
|
Secondary ID(s)
|
|
TUM-Chir-002/2010
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|