InfectionsIMSNCT02395159
Reduction of Groin Wound Infections After Vascular Surgery by Using an Incision Management System (IMS)
A study testing Prevena™ IMS and sterile plaster dressings in people with Infections, run by RWTH Aachen University at 2 sites in Germany.
Trial summary
Comparison of the Prevena™ IMS with the standard wound management method of sterile plaster in vascular surgery patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections
- What is being tested?
- Prevena™ IMS and sterile plaster dressings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 2 sitesGermany
- Study dates
- Jul 2015to 10 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- vascular surgery via right or left inguinal approach
- nicotine abuse (active or according to medical condition)
- risk factors:
- cardiac risk factors (arterial hypertension, coronary heart disease, status after myocardial infarction)
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Hospital Aachen, vascular surgery
Aachen, 52074
Marienhospital Wiiten, vascular surgery
Witten, 58452
About this study
Official 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)
Comparison of the Prevena™ IMS with the standard wound management method of sterile plaster in vascular surgery patients.
Read the detailed description
Comparison of the Prevena™ IMS with the standard wound management method of sterile plaster in vascular surgery patients.
The aim is to demonstrate that the application of the Prevena™ IMS significantly reduces the incidence of postoperative wound infections. The wound infections will be classified according to Szilagyi.
The treatment phase begins following vascular surgery with wound management using either the Prevena™ IMS or a standard wound dressing, depending on the group to which the patient was randomly assigned. It involves a minimum stay of 7 and maximum 10 days in hospital.
- Conditions
- Infections
- Being tested
- Prevena™ IMS, sterile plaster dressings
- Keywords
- vascular surgery patients, wound management
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevena™ IMSDevice
Prevena™ IMS is intended for the management of the surgical incision environment and surrounding healthy skin in patients with a risk of postoperative complications such as infections. This entails the maintenance of a closed environment around the incision by applying a negative pressure wound therapy system.
The corresponding dressing is known under the name Prevena™ Dressing. The layer closest to the skin comprises silver foil, which reduces the microbial colonisation of cells.
sterile plaster dressingsOther
standard wound management method of sterile plaster dressings
| Study group | Role | What they receive |
|---|---|---|
| Prevena™ IMS | Experimental | The patients in the experimental arm will be treated with the Prevena™ IMS seven days after the surgery Receives: Device: Prevena™ IMS |
| sterile plaster dressings | Other | The wound will be treated with the conventional wound management method of sterile plaster dressing. Receives: Other: sterile plaster dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound infections
The primary objective is the occurrence of inguinal wound infections following surgery. Wound infections will be classified according to Szilagyi.
Measured: 7 days after the surgery
Secondary outcomes (5)
length of hospital stay
Measured: up to 10 days
antibiotic therapy
Measured: up to 30 days
revision surgery
Measured: up to 30 days
necessity of alternative wound dressings
Measured: up to 30 days
prolongation of ambulant treatment
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2017
- Study completion10 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jochen Grommes, Principal investigator, University Hospital, Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395159
- Sponsor's protocol ID
- 14-048
- Acronym
- IMS
- Status last verified
- Oct 2017
- First submitted
- 16 Mar 2015
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.
PubMed 41159585Cristino MA, Nakano LC, Vasconcelos V, Correia RM, Flumignan RL. Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction. Cochrane Database Syst Rev. 2025 Apr 22;4(4):CD015192. doi: 10.1002/14651858.CD015192.pub2.
PubMed 40260835
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT02395159
- Acronym / sponsor ID
- IMS / 14-048
- Conditions
- Infections
- Keywords
- vascular surgery patients, wound management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- 10 Oct 2017 (actual)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of the Prevena™ IMS with the standard wound management method of sterile plaster in vascular surgery patients.
Detailed description
Comparison of the Prevena™ IMS with the standard wound management method of sterile plaster in vascular surgery patients.
The aim is to demonstrate that the application of the Prevena™ IMS significantly reduces the incidence of postoperative wound infections. The wound infections will be classified according to Szilagyi.
The treatment phase begins following vascular surgery with wound management using either the Prevena™ IMS or a standard wound dressing, depending on the group to which the patient was randomly assigned. It involves a minimum stay of 7 and maximum 10 days in hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevena™ IMS | Experimental | Device: Prevena™ IMSThe patients in the experimental arm will be treated with the Prevena™ IMS seven days after the surgery |
| sterile plaster dressings | Other | Other: sterile plaster dressingsThe wound will be treated with the conventional wound management method of sterile plaster dressing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- vascular surgery via right or left inguinal approach
- nicotine abuse (active or according to medical condition)
- risk factors:
- previous vascular surgery with inguinal approach
- signed informed consent form
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevena™ IMSPrevena™ IMS is intended for the management of the surgical incision environment and surrounding healthy skin in patients with a risk of postoperative complications such as infections. This entails the maintenance of a closed environment around the incision by applying a negative pressure wound therapy system. The corresponding dressing is known under the name Prevena™ Dressing. The layer closest to the skin comprises silver foil, which reduces the microbial colonisation of cells. | Device | Prevena™ IMS |
| sterile plaster dressingsstandard wound management method of sterile plaster dressings | Other | sterile plaster dressings |
Primary outcome
wound infections
Time frame: 7 days after the surgery
The primary objective is the occurrence of inguinal wound infections following surgery. Wound infections will be classified according to Szilagyi.
5 secondary outcomes
length of hospital stay
Time frame: up to 10 days
antibiotic therapy
Time frame: up to 30 days
revision surgery
Time frame: up to 30 days
necessity of alternative wound dressings
Time frame: up to 30 days
prolongation of ambulant treatment
Time frame: up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Derived from this study: PubMed 41159585Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.
- Derived from this study: PubMed 40260835Cristino MA, Nakano LC, Vasconcelos V, Correia RM, Flumignan RL. Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction. Cochrane Database Syst Rev. 2025 Apr 22;4(4):CD015192. doi: 10.1002/14651858.CD015192.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jochen Grommes principal investigator
University Hospital, Aachen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevena™ IMS and sterile plaster dressings in people with Infections, run by RWTH Aachen University at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound infections (time frame: 7 days after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02395159, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.