Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy

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.

Conditions

• Surgical Site Infection
• Length of Stay
• Seroma
• Hematoma

Interventions

DEVICE

Closed incision negative pressure therapy versus standard dressing after emergency abdominal laparotomies

Target population is every patient undergoing a laparotomic procedure and responding to inclusion criteria marked in paragraph 3.8 (see forward) A member of the medical surgery team should apply the PREVENA just after the surgical procedure. A medical member (nurse specialist in wound care) of the surgical team removes the dressing. All other manipulations of the therapy unit, the connector and the cartridge can be carried out by any nurse practitioner in hospital or extra hospital environment but must warn the investigators. The aspiration will be stopped 24 hours before and the dressing is removed by a nurse at home or in the hospital. The specialized nurse who will take a photo and assess the condition of the wound in the treatment room. One of the investigators, non-operators, who will also assess the condition of the wound by photo.

Sponsors & Collaborators

• Meyer Jeremy. PhD. Co-investigator. University Hospital, Geneva.

  collaborator UNKNOWN

• Peloso Andrea. PhD. Co-investigator. University Hospital, Geneva.

  collaborator UNKNOWN

• Ris Frederic. P.D. Clinical Professor. University Hospital, Geneva.

  collaborator UNKNOWN

• Toso Christian. PhD. Head of visceral surgery. University Hospital, Geneva.

  collaborator UNKNOWN

• Buchs C. Nicolas. P.D. Director of the project. University Hospital, Geneva.

  collaborator UNKNOWN

• University Hospital, Geneva

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-01

Primary Completion

2023-09-01

Completion

2025-09-01

FDA Device

Yes