Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
644 participants
INTERVENTIONAL
2013-11-30
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
To prove a significant effect of the treatment intervention in the EVAR arm with a wound infection rate reduction from previously 4.4% to 1%, 80% power, 5% significance level and Including a margin for loss to follow-up, the EVAR arm requires 497 inguinal incisions. Assuming a surgical site infection rate reduction from 30% to 10% in the OPEN arm of the study, 80% power and 5% significance level, a total of 147 inguinal incisions is required.
We conducted an unannounced interim analysis for a conference presentation that was conducted by the study's principal investigators Stefan Acosta and Julien Hasselmann. Staff in charge of the day-to-day activities of the trial were not involved or actively informed of this. We believe that using an objective wound assessment tool (ASEPSIS score) minimizes any potential bias associated with the interim analysis.
Since the vascular center Malmö has started using closure-devices for almost all EVAR cases and thereby creating virtually no wounds to assess, we have started a multi center extension of the EVAR arm to Örebro University Hospital to be able to include the outstanding cases.
FUNDING
The trial has been funded by public Swedish funds stemming from the Southmost region in Sweden (Region Skåne), the Skåne University Hospital and the Hulda Almroth foundation since 2015 and adds up to a total of 2.81 million SEK (about 311,000 USD). In addition the research group received an unrestricted unconditional research grant of 15,550 USD and a donation of 100 PICO dressing kits from Smith and Nephew in 2013.
ALF (Agreement on medical education and research) funding has been granted for the time period 2019 - 2022 but has not yet been defined monetarily.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard wound dressing OPEN
Standard wound dressing
No interventions assigned to this group
PICO dressing OPEN
Negative pressure wound therapy with PICO (Smith \& Nephew)
Negative pressure wound therapy with PICO (Smith & Nephew)
Negative wound pressure therapy
Standard dressing EVAR
Standard wound dressing
No interventions assigned to this group
PICO dressing EVAR
Negative pressure wound therapy with PICO (Smith \& Nephew)
Negative pressure wound therapy with PICO (Smith & Nephew)
Negative wound pressure therapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Negative pressure wound therapy with PICO (Smith & Nephew)
Negative wound pressure therapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Elective vascular surgery
* Inguinal incision (transverse or longitudinal)
* Capable of understanding the study information and giving written informed consent
Exclusion Criteria
* Ongoing infection in inguinal area
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Stefan Acosta
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Stefan Acosta
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stefan Acosta, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Vascular Centre, Malmö, Skåne University Hospital
Julien Hasselmann, MD
Role: PRINCIPAL_INVESTIGATOR
Vascular Centre, Malmö, Skåne University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vascular Centre, Malmö, Skåne University Hospital
Malmo, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Stefan Acosta, MD PhD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Hasselmann J, Bjork J, Svensson-Bjork R, Acosta S. Inguinal Vascular Surgical Wound Protection by Incisional Negative Pressure Wound Therapy: A Randomized Controlled Trial-INVIPS Trial. Ann Surg. 2020 Jan;271(1):48-53. doi: 10.1097/SLA.0000000000003364.
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:CD015022. doi: 10.1002/14651858.CD015022.pub2.
Svensson-Bjork R, Hasselmann J, Asciutto G, Zarrouk M, Bjork J, Bilos L, Pirouzram A, Acosta S. Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections Using Fascia Closure After EVAR-A Randomized Trial. World J Surg. 2022 Dec;46(12):3111-3120. doi: 10.1007/s00268-022-06740-5. Epub 2022 Oct 14.
Rezk F, Astrand H, Acosta S. Incisional negative pressure wound therapy for the prevention of surgical site infection after open lower limb revascularization - Rationale and design of a multi-center randomized controlled trial. Contemp Clin Trials Commun. 2019 Oct 14;16:100469. doi: 10.1016/j.conctc.2019.100469. eCollection 2019 Dec.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Dnr 2013/322
Identifier Type: -
Identifier Source: org_study_id