Clinical trial NCT04496180: Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy
Official title: Standard Wound Dressing Versus Prophylactic Negative-pressure Wound Therapy After Emergency Laparotomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Surgical Site Infection
Length of Stay
Seroma
Hematoma
Keywords: pNPWT
PREVENA
SSI
morbidity
dehiscence
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Meyer Jeremy. PhD. Co-investigator. University Hospital, Geneva.
name: Peloso Andrea. PhD. Co-investigator. University Hospital, Geneva.
name: Ris Frederic. P.D. Clinical Professor. University Hospital, Geneva.
name: Toso Christian. PhD. Head of visceral surgery. University Hospital, Geneva.
name: Buchs C. Nicolas. P.D. Director of the project. University Hospital, Geneva.
First posted: 2020-08-03
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Study Type: Interventional (Clinical Trial)
* Estimated Enrollment: 334
* Allocation: Randomized control trial
* Intervention Model: Parallel Assignment
* Intervention Model Description: 2 separate treatment arms
* Primary Purpose: Prevention
* Official Title: Standard wound dressing versus prophylactic negative-pressure wound therapy after emergency laparotomy
* Estimated Study Start Date: 09.2020
* Estimated Primary Completion Date:09.2021
* Estimated Study Completion Date: 09.2025
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Length of stay (LOS) in days.
timeFrame: 30 days post procedure
measure: 30-day Return to Operating Room (ROR)
timeFrame: 30 days post procedure
measure: Incidence rates of wound complications
timeFrame: 30 days post procedure
Other outcomes:
measure: A rate of parietal incisional hernia apparition after surgery
timeFrame: 2 years post procedure
Locations:
Study officials:
References:
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