PICO Above Incisions After Vascular Surgery

November 20, 2023 updated by: Stefan Acosta, Skane University Hospital

PICO Versus Standard Dressing on Groin Incisions After Vascular Surgery - a Prospective Randomized Trial (INVIPS Trial)

The wound infection rate in the groin after vascular surgery has been denoted to be high since the wound surveillance register started in 2005. The current wound infection rate based on a validation study was 22.9% (24/105 patients with groin incision(s) between 1 March to 30 June in 2012). This randomized controlled trial aims to evaluate if negative pressure wound therapy on closed inguinal incisions (INPWT) after vascular surgical procedures can reduce the risk for surgical site infections and other wound complications.

Study Overview

Status

Recruiting

Conditions

Detailed Description

As published in the study´s rational and design paper (DOI: 10.4236/ss.2015.612080), we conducted a reanalysis of the material that the original power calculation was based on and included elective cases only which led to a slightly different number of cases needed. Furthermore, it became clear that there were big differences in the infection rates of EVAR (endovascular aortic repair) and open vascular procedures and therefore the need to split the study into two arms, an EVAR arm and an OPEN arm.

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.

Study Type

Interventional

Enrollment (Estimated)

644

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Malmö, Sweden
        • Recruiting
        • Vascular Centre, Malmö, Skåne University Hospital
        • Contact:
          • Stefan Acosta, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients 18 years of age and above
  • Elective vascular surgery
  • Inguinal incision (transverse or longitudinal)
  • Capable of understanding the study information and giving written informed consent

Exclusion Criteria:

  • Emergency surgery
  • Ongoing infection in inguinal area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard wound dressing OPEN
Standard wound dressing
Experimental: PICO dressing OPEN
Negative pressure wound therapy with PICO (Smith & Nephew)
Negative wound pressure therapy
No Intervention: Standard dressing EVAR
Standard wound dressing
Experimental: PICO dressing EVAR
Negative pressure wound therapy with PICO (Smith & Nephew)
Negative wound pressure therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound infection rate
Time Frame: Wounds will be checked at 3 month follow-up
ASEPSIS (Additional treatment, the presence of Serous discharge, Erythema, Purulent exudate, and Separation of the Deep tissues, the isolation of bacteria, and the duration of inpatient stay) score. Min 0 p, max > 40 p, higher values worse outcome
Wounds will be checked at 3 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Costs of treatment
Time Frame: Costs will be checked at 3 months of follow-up
Systematic assessment of overall costs
Costs will be checked at 3 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Stefan Acosta, MD PhD, Vascular Centre, Malmö, Skåne University Hospital
  • Principal Investigator: Julien Hasselmann, MD, Vascular Centre, Malmö, Skåne University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 25, 2013

First Submitted That Met QC Criteria

July 29, 2013

First Posted (Estimated)

July 31, 2013

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr 2013/322

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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