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

April 27, 2021 updated by: Abbassi Ziad, University Hospital, Geneva

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

334

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PREVENA (CiPNT)

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

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.

Other Names:
  • PREVENA
ACTIVE_COMPARATOR: Simple dressing
Simple dressing; standard, waterproof dressing applied to wound
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.

Other Names:
  • PREVENA

What is the study measuring?

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
Time Frame: up to 30 days post procedure

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.
Time Frame: 30 days post procedure
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)
Time Frame: 30 days post procedure
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
Time Frame: 30 days post procedure
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
A rate of parietal incisional hernia apparition after surgery
Time Frame: 2 years post procedure

This complication rate is multifactorial can be related to:

  • An wall abcess
  • Obesity with a BMI > 35 Kg/m2
  • medications
  • Malnutrition
  • Being an elderly adult
  • Smoking
  • Cancer
  • a weak immune system
  • diabetes
2 years post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Collaborators

Meyer Jeremy. PhD. Co-investigator. University Hospital, Geneva.
Peloso Andrea. PhD. Co-investigator. University Hospital, Geneva.
Ris Frederic. P.D. Clinical Professor. University Hospital, Geneva.
Toso Christian. PhD. Head of visceral surgery. University Hospital, Geneva.
Buchs C. Nicolas. P.D. Director of the project. University Hospital, Geneva.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2021

Primary Completion (ANTICIPATED)

September 1, 2023

Study Completion (ANTICIPATED)

September 1, 2025

Study Registration Dates

First Submitted

July 16, 2020

First Submitted That Met QC Criteria

July 30, 2020

First Posted (ACTUAL)

August 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNGeneva

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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