UnknownNot Applicable

Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy

334 participantsStarted 2021-09-01

Plain-language summary

Post-operative wound complications in abdominal surgery have a major impact on patient outcomes and the real impact of Closed incision negative pressure therapy (CINVt) is not clear in the literature moreover concerning its potential economic benefits The hypothesis of this study is that CINPt has the potential to reduce Surgical Site Infections. Secondly the investigators aim to study the economic impact of CINPt used after abdominal emergency laparotomies.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patient * ≥10cm emergency median laparotomy * Abdominal wall and skin closure in first intent * Septic peritoneal cavity (purulent and/or fecaloid free liquid and/or abscess) * Informed written consent Exclusion Criteria: * No abdominal wound closure in first intent * Allergy or hypersensitivity to silver * Application of a mesh for abdominal wall closure * Patients under corticosteroids or other immunosuppressive treatment. * Women who are pregnant or breast-feeding. * Intention to become pregnant during the course of the study. * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant. * Previous enrolment in the current study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To determine if the use of prophylactic negative-pressure wound therapy (Prevena) reduces the incidence of superficial surgical site infection after emergency laparotomy in patients at high-risk for SSI

Timeframe: up to 30 days post procedure

Trial details

NCT IDNCT04496180

SponsorUniversity Hospital, Geneva

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-01

Contact for this trial

Ziad Abbassi, M.D.

0041766931667 Ziad.abbassi@hcuge.ch

View on ClinicalTrials.gov More Surgical Site Infection trials