Prevention of infection in peripheral arterial reconstruction of the lower limb.
Rebeca M Correia, Luis Cu Nakano, Vladimir Vasconcelos...
https://pubmed.ncbi.nlm.nih.gov/41159585/Actively Recruiting
Led by Stefan Acosta · Updated on 2024-11-29
644
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating whether negative pressure wound therapy using the PICO device on closed groin incisions after vascular surgery can lower the risk of surgical site infections and other wound problems. This randomized trial focuses on patients undergoing elective vascular procedures, separating cases into two groups based on the type of surgery endovascular aortic repair EVAR and open vascular surgery. The study was designed after noting a high infection rate of 22.9% in groin wounds following vascular surgery. Participants receive either standard wound dressings or the PICO negative pressure wound therapy on their groin incisions. The study includes two arms one for EVAR surgery and one for open vascular surgery. The EVAR arm requires 497 groin incisions to assess a reduction in infection rates, while the open surgery arm needs 147 incisions. This trial is conducted across multiple centers to gather sufficient data. During the study, wounds will be checked at a 3-month follow-up to measure infection rates using an objective tool. Researchers will also evaluate the overall treatment costs at this time. Participants provide written informed consent and are monitored for wound healing and complications. The trial is led by Stefan Acosta and funded by public Swedish sources and Smith & Nephew, with the study ongoing since 2013.
CONDITIONS
PICO Above Incisions After Vascular Surgery
S
Stefan Acosta, MD PhD
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Stefan Acosta
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants undergo elective vascular surgery involving a groin incision and receive either standard wound dressing or negative pressure wound therapy with PICO.
1 visit (in-person)
Duration - Up to 3 months after surgery
Participants are followed to monitor wound healing and check for infection.
Visits at surgery and 3-month follow-up
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
Have more questions? Get in touch with our team for quick support
Rebeca M Correia, Luis Cu Nakano, Vladimir Vasconcelos...
https://pubmed.ncbi.nlm.nih.gov/41159585/Robert Svensson-Björk, Julien Hasselmann, Giuseppe Asciutto...
https://pubmed.ncbi.nlm.nih.gov/36241857/Francis Rezk, Håkan Åstrand, Robert Svensson-Björk...
https://pubmed.ncbi.nlm.nih.gov/38042513/Francis Rezk, Håkan Åstrand, Stefan Acosta
https://pubmed.ncbi.nlm.nih.gov/31701043/Julien Hasselmann, Jonas Björk, Robert Svensson-Björk...
https://pubmed.ncbi.nlm.nih.gov/31283565/Stefan Acosta
Lead Sponsor