WoundNCT01913132
PICO Above Incisions After Vascular Surgery
A study testing Negative pressure wound therapy with PICO (Smith & Nephew) in people with Wound and Infection, run by Stefan Acosta at 1 site in Sweden.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Negative pressure wound therapy with PICO (Smith & Nephew)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 644 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2013to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- Emergency surgery
- Ongoing infection in inguinal area
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Vascular Centre, Malmö, Skåne University Hospital
Malmö
Stefan Acosta, MD PhD
About this study
Official title: 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.
Read the 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.
- Being tested
- Negative pressure wound therapy with PICO (Smith & Nephew)
- Keywords
- Negative pressure wound therapy, Vascular Surgery, Inguinal incisions
- Medical subject headings
- Wounds and Injuries, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative pressure wound therapy with PICO (Smith & Nephew)Device
Negative wound pressure therapy
| Study group | Role | What they receive |
|---|---|---|
| Standard wound dressing OPEN | No intervention | Standard wound dressing |
| PICO dressing OPEN | Experimental | Negative pressure wound therapy with PICO (Smith \& Nephew) Receives: Device: Negative pressure wound therapy with PICO (Smith & Nephew) |
| Standard dressing EVAR | No intervention | Standard wound dressing |
| PICO dressing EVAR | Experimental | Negative pressure wound therapy with PICO (Smith \& Nephew) Receives: Device: Negative pressure wound therapy with PICO (Smith & Nephew) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound infection rate
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
Measured: Wounds will be checked at 3 month follow-up
Secondary outcomes (1)
Overall Costs of treatment
Systematic assessment of overall costs
Measured: Costs will be checked at 3 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for WoundStudies 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
- Model description
- 2 study subgroups: 1) OPEN arm for open procedures 2) EVAR arm for endovascular aortic repair
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 644 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stefan Acosta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefan Acosta, Skane University Hospital
- Investigators
- Stefan Acosta, MD PhD, Principal investigator, Vascular Centre, Malmö, Skåne University HospitalJulien Hasselmann, MD, Principal investigator, Vascular Centre, Malmö, Skåne University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913132
- Sponsor's protocol ID
- Dnr 2013/322
- Status last verified
- Nov 2024
- First submitted
- 25 Jul 2013
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31283565Correia 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 41159585Rezk F, Astrand H, Svensson-Bjork R, Hasselmann J, Nyman J, Butt T, Bilos L, Pirouzram A, Acosta S. Multicenter parallel randomized trial evaluating incisional negative pressure wound therapy for the prevention of surgical site infection after lower extremity bypass. J Vasc Surg. 2024 Apr;79(4):931-940.e4. doi: 10.1016/j.jvs.2023.11.043. Epub 2023 Nov 30.
PubMed 38042513Svensson-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.
PubMed 36241857Rezk 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.
PubMed 31701043
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PICO Versus Standard Dressing on Groin Incisions After Vascular Surgery - a Prospective Randomized Trial (INVIPS Trial)
- ClinicalTrials.gov ID
- NCT01913132
- Acronym / sponsor ID
- Dnr 2013/322
- Keywords
- Negative pressure wound therapy, Vascular Surgery, Inguinal incisions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 644 participants (estimated)
- Lead sponsor
- Stefan AcostaUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Jul 2013 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
- Model description
- 2 study subgroups: 1) OPEN arm for open procedures 2) EVAR arm for endovascular aortic repair
| Arm | Type | Receives |
|---|---|---|
| Standard wound dressing OPEN | No intervention | –Standard wound dressing |
| PICO dressing OPEN | Experimental | Device: Negative pressure wound therapy with PICO (Smith & Nephew)Negative pressure wound therapy with PICO (Smith \& Nephew) |
| Standard dressing EVAR | No intervention | –Standard wound dressing |
| PICO dressing EVAR | Experimental | Device: Negative pressure wound therapy with PICO (Smith & Nephew)Negative pressure wound therapy with PICO (Smith \& Nephew) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Emergency surgery
- Ongoing infection in inguinal area
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 |
|---|---|---|
| Negative pressure wound therapy with PICO (Smith & Nephew)Negative wound pressure therapy | Device | PICO dressing EVAR, PICO dressing OPEN |
Primary outcome
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
1 secondary outcome
Overall Costs of treatment
Time frame: Costs will be checked at 3 months of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Results publication: PubMed 31283565Hasselmann 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.
- 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 38042513Rezk F, Astrand H, Svensson-Bjork R, Hasselmann J, Nyman J, Butt T, Bilos L, Pirouzram A, Acosta S. Multicenter parallel randomized trial evaluating incisional negative pressure wound therapy for the prevention of surgical site infection after lower extremity bypass. J Vasc Surg. 2024 Apr;79(4):931-940.e4. doi: 10.1016/j.jvs.2023.11.043. Epub 2023 Nov 30.
- Derived from this study: PubMed 36241857Svensson-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.
- Derived from this study: PubMed 31701043Rezk 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.
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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.
Stefan Acosta, MD PhD principal investigator
Vascular Centre, Malmö, Skåne University Hospital
Julien Hasselmann, MD principal investigator
Vascular Centre, Malmö, Skåne University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative pressure wound therapy with PICO (Smith & Nephew) in people with Wound and Infection, run by Stefan Acosta at 1 site in Sweden.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefan Acosta, MD PhD (+4640331000, stefan.acosta@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound infection rate (time frame: Wounds will be checked at 3 month follow-up). 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 NCT01913132, which also lists 5 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 29 Nov 2024.