Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy (CiPNT/SSI)

University Hospitals (UH)

Status: Not yet enrolling

Conditions: Length of Stay; Seroma; Surgical Site Infection; Hematoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04496180

UNGeneva

Details and patient eligibility

About

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.

Full description

Emergency laparotomies lead to increased morbidity and mortality rates. In this scenario the most frequent wound occurrences are represented by wound infections, skin dehiscence or parietal hernias.

Despite standard surgical aseptically technique and perioperative prevention management of infections (e.g. antibiotics), wound complications after emergency laparotomies are still an important unmet challenge.

Moreover, all these complications increase the cost of care requiring new managements.

CINPt has been longly used to favour the successful healing of a plethora of open wounds.

In particular CINPt is based on the application of local negative pressure to the wound surface. In case of open abdomens, the procedure is performed by applying a sterile abdominal dressing, which consists of a fenestrated soft plastic non-adherent layer with enclosed central foam, which is placed on the surface of the viscera. Then, two layers of porous sponge dressings are applied over the plastic layer. Finally, a transparent adhesive is placed over the foam and the wound to seal the abdominal cavity. The entire system is then connected, by suction tubes, to a device which ubiquitously applies negative pressure (cyclically or continuously) on the surface. The fluid from the wound is collected into a container. The benefits of negative pressure wound therapy have been reported to include removal of infectious material, reduction in oedema and improved perfusion to tissue. Since few years, a new negative pressure wound therapy has been created for closed wounds to reduce time of healing and avoid wound complications.

Enrollment: 334 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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334 participants in 2 patient groups

PREVENA (CiPNT)

Experimental group

Description:

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 all parts 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.

Treatment:

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

Simple dressing

Active Comparator group

Description:

Simple dressing; standard, waterproof dressing applied to wound

Treatment:

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