Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Standard Wound Dressing Versus Prophylactic Negative-pressure Wound Therapy After Emergency Laparotomy: a Randomized Controlled Trial

Conditions
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Surgical Site Infection, Length of Stay, Seroma, Hematoma

Intervention / Treatment
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* Device: Closed incision negative pressure therapy versus standard dressing after emergency abdominal laparotomies


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PREVENA (CiPNT)<br>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. | Device: Closed incision negative pressure therapy versus standard dressing after emergency abdominal laparotomies<br>* 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.<br>* Other names: PREVENA;|
| Active Comparator: Simple dressing<br>Simple dressing; standard, waterproof dressing applied to wound | Device: Closed incision negative pressure therapy versus standard dressing after emergency abdominal laparotomies<br>* 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.<br>* Other names: PREVENA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Any SSI may cause redness, delayed healing, fever, pain, tenderness, warmth, or swelling. Superficial site infection will be assessed by Wound Classification System Using the American College of Surgeons National Surgical Quality Improvement Program ACS-NSQIP : Clean; these are uninfected operative wounds in which no inflammation. Clean/contaminated; These are operative wounds in which the respiratory, alimentary, genital, or urinary tract is entered Under controlled conditions and without unusual contamination. Contaminated; These include open, fresh, accidental wounds, operations with major breaks in sterile technique or gross spillage from the gastrointestinal tract, and incisions in which acute, non-purulent inflammation is encountered. Dirty ; These include old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera. | up to 30 days post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay (LOS) in days. | LOS is defined as days from operation to discharge; 30d LOS is defined as the index LOS plus all readmission days within 30d related to any wound complications. | 30 days post procedure | 
| 30-day Return to Operating Room (ROR) | Reoperation for wound complication within 30 days involving incision and drainage in the operating room; opening the skin to drain a superficial soft tissue infection at bedside or in the office is not considered reoperation. | 30 days post procedure | 
| Incidence rates of wound complications | Individual rates of the incidence of each of the following: dehiscence (skin or fascia), seroma, lymph leak, infection, hematoma, ischemia and necrosis. | 30 days post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pNPWT, PREVENA, SSI, morbidity, dehiscence