ClinicalTrials.gg
Status unknownNCT03460262PICOUpdated Mar 9, 2018

Negative Pressure Wound Therapy for Prevention of Groin Infection Following Vascular Surgery

An interventional study of Standard cutiplast® and PICO® in Infection Wound, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-09.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Not yet recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Surgical site infection in vascular surgery is a relatively common event with reported incidence as high as 43%. When considering the groin alone, the incidence is around 20% (30% when considering any wound complication). This complication may sometimes lead to heavier complication (leg amputation, longer hospital stay, high costs...) and affects the early postoperative quality of life of the patients.

02

Conditions studied

  • Infection Wound

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03

In context

Wound Infection

270 studies on the registry are indexed under Wound Infection; 33 are open to participants now.

This study's planned enrollment of 160 is above the median of 141 across 228 interventional studies indexed under Wound Infection.

Browse Wound Infection studies →

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 350 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Every high-risk patient (meeting one of the criteria of table I) undergoing vascular surgery with groin incision (without ongoing infection)

Exclusion criteria

Exclusion Criteria:

  • Patients who need a transverse incision before EndoVascular Aortic Repair procedure, considering that in our experience surgical site infection almost never occurs after these procedures and patients with mental incapacities.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (estimated)

Study arms

  • Active comparator
    Standard dressing-Cutiplast®

    Device: Standard cutiplast®

  • Experimental
    Negative pressure wound therapy-PICO®

    Device: PICO®

Interventions

  • DeviceStandard cutiplast®

    Our standard dressing consists in a usual ready-to-use Smith and Nephew Cutiplast®. This dressing is open 48 hours after the operation (CDC recommendation) for the first time and then changed every day after wound disinfection.

  • DevicePICO®

    PICO® is a negative pressure wound therapy consisting in a 4 layers ready-to-use dressing connected to a small console, responsible for the aspiration. The system is canister free. The fluid drained from the wound is lost by evaporation for 80% of it and only 20% remains in the dressing. This permits to the dressing to be kept in place for maximum 7 days. The wound is not checked during the hospital stay, allowing the patient to leave the hospital earlier after the operation.

06

What researchers measure

Primary outcomes

  1. The rate of wound complications

    Time frame: at one year

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: Undecided — It is not decided yet.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2018; primary completion for Nov 2019, 20 months later.

Of 59 non-industry interventional studies with no phase under Wound Infection, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 53. This study's planned 20 months is close to that.

Counting every sponsor, half of 64 studies reached it within 19 months; a quarter within 13 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2018
First posted
Mar 9, 2018
StartEst.
Mar 15, 2018
Primary completionEst.
Nov 30, 2019
CompletionEst.
Nov 30, 2019
Last update
Mar 9, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03460262
Responsible party
Sponsor
First posted
Mar 9, 2018
Start date
Mar 15, 2018 (estimated)
Primary completion
Nov 30, 2019 (estimated)
Completion
Nov 30, 2019 (estimated)
Last update
Mar 9, 2018

Study contacts

Parla Astarci, MD, PhD
Contact
parla.astarci@uclouvain.be
0032 2 764 ext. 6412
Julien Possoz, MD
Contact
julien.possoz@uclouvain.be
0032 2 764 ext. 8069
Parla Astarci, MD, PhD
principal investigator · Cliniques universitaires Saint-Luc

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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