|
Main
|
|
Note: This record shows only 22 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:
|
16 December 2017 |
|
Main ID: |
NCT02395159 |
|
Date of registration:
|
16/03/2015 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Reduction of Groin Wound Infections After Vascular Surgery by Using an Incision Management System (IMS)
IMS |
|
Scientific title:
|
Reduction of Groin Wound Infections After Vascular Surgery in Patients With Risk Factors by the Use a Negative Pressure Wound Incision Management System (KCI Prevena) |
|
Date of first enrolment:
|
July 2015 |
|
Target sample size:
|
204 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02395159 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Contacts
|
|
Name:
|
Jochen Grommes |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University Hospital, Aachen |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- vascular surgery via right or left inguinal approach
- nicotine abuse (active or according to medical condition)
- risk factors:
1. cardiac risk factors (arterial hypertension, coronary heart disease, status after
myocardial infarction)
2. metabolic disorders (diabetes mellitus type I type II, lipopathy or
hyperhomocysteinemia) or chronic or acute renal insufficiency
- previous vascular surgery with inguinal approach
- signed informed consent form
- persons who are legally competent and mentally able to comprehend and follow the
instructions of study personnel
Exclusion Criteria:
- local skin infections (fungal infections, acne)
- pregnant and breast-feeding women
- simultaneous participation in another clinical trial
- persons who have been committed to an institution by court or administrative order
- persons in a dependency or employment relationship with the sponsor or investigator
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Infections
|
|
Intervention(s)
|
|
Other: sterile plaster dressings
|
|
Device: Prevena™ IMS
|
|
Primary Outcome(s)
|
|
wound infections
[Time Frame: 7 days after the surgery]
|
|
Secondary Outcome(s)
|
|
prolongation of ambulant treatment
[Time Frame: up to 30 days]
|
|
revision surgery
[Time Frame: up to 30 days]
|
|
length of hospital stay
[Time Frame: up to 10 days]
|
|
antibiotic therapy
[Time Frame: up to 30 days]
|
|
necessity of alternative wound dressings
[Time Frame: up to 30 days]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|