Efficacy of NPWT in Reducing the Incidence of Wound Infection After Pancreatic Surgery

May 6, 2020 updated by: Azienda Ospedaliera Universitaria Integrata Verona

Efficacy of a Disposable Negative Wound Pressure Device in Reducing the Incidence of Non-organ Space Surgical Site Infection After Clean-contaminated Pancreatic Resections: a Randomized Controlled Trial

A disposable negative wound pressure device will be compared to standard sterile wound dressing in reducing the rate of wound infection after clean-contaminated surgical procedures on biliary tract and pancreas in patients at high risk for wound infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The use of specific protocols for antisepsis, sterilization and infections' prophylaxis is widely diffused, but, however, surgical site infection rate is still high. Wound infection is often considered as a minor morbidity if compared with other complications, but it is able to considerably increase the length of hospital stay, health care and assistance related costs affecting patients' quality of life. The Center for Disease Control and Prevention (CDC) has published specific guidelines for surgical site infection (SSI) prevention that includes hairs removal, intravenous antibiotics on the basis of the type of procedure planned for that patient, skin antisepsis, surgical team antisepsis, sterility, blood glucose levels control, body temperature control and optimal perfusion of all tissues. At the end of the surgical procedure, surgical incision is covered with a sterile dressing that usually is changed after 24/48 hours. Clean-contaminated procedures like pancreaticoduodenectomy (PD), total pancreatectomy (TP) and palliative procedures like gastric by-pass and hepaticojejunostomy GEA/HJ) are considered at high complexity with a high incidence of SSI, especially dealing with patients at high surgical risk. Since from the introduction of negative wound pressure therapy in 1997, these devices have been used only for the treatment of acute and chronic wounds with loss of tissue, but recently have also been proposed in the setting of SSI prevention. Negative wound pressure systems have higher costs, the use in the outpatients setting may be complex consequently the use in the setting of SSI prevention could not result cost-effective.

The rationale for the use of negative pressure therapy in the prevention of SSI relies in the complete clearance of dead-space under the incision, fluids and blood removal with consequent reduction of fluids infections, edema reduction, blood flow improvement and tissue oxygenation. Similar results can be obtained through a less expensive, disposable, canisterless, negative pressure wound therapy device (Pico®, Smith&Nephew). This system is cheaper, is portable, and can produce a continue vacuum with a nominal pressure of -80mmHg being able to achieve a rapid discharge at home with less frequent medications, improved comfort and aesthetic result.

The following study is designed to assess the effect of a disposable, canisterless, negative pressure wound therapy device in the reduction of SSI in high risk patients if compared with a sterile standard dressing after major pancreatic procedures.

Study Type

Interventional

Enrollment (Actual)

100

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 Locations

  • Italy
      • Verona, Italy, 37134
        • Ospedale Policlinico GB Rossi

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:

  • Age > 18
  • Informed consent
  • HPB clean-contaminated procedures (PD, TP and GEA/HJ)
  • Median laparotomy
  • Compliance with a follow-up protocol

  • High risk for SSI (at least one of the following):

    • Body Mass Index > 30kg/m2
    • Diabetes mellitus type I or II
    • Use of steroids
    • Neoadjuvant therapy
    • ASA ≥ 3
    • Charlson Comorbidity Index 1
    • Time of surgery > 360'
    • Estimated blood loss > 1L

Exclusion Criteria:

  • Previous open surgery of the abdomen
  • Unable to give informed consent

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: Negative wound pressure device (PICO)
The disposable negative wound pressure device (PICO) will be used to cover the midline incision. The dressing is changed on POD3 and removed on POD7. Data are collected on POD3, POD7 and POD30.
Device: Disposable negative wound pressure device (PICO)
Application of a disposable negative wound pressure device for surgical site infection prevention.
ACTIVE_COMPARATOR: Standard sterile dressing
The OPsite post-op visible standard sterile dressing will be used to cover the midline incision. Dressing is changed q48h. Data are collected on POD3, POD7 and POD30.
Device: OPsite post-op visible standard sterile dressing
Application of a standard sterile wound dressing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Site Infection (non-organ space)
Time Frame: 30 days from index surgery
Superficial + deep surgical site infection as defined by CDC
30 days from index surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of discontinuation of negative wound pressure therapy
Time Frame: 7 days from index surgery
Discontinuation of therapy due to patient choice
7 days from index surgery
Incidence of seromas
Time Frame: 30 days from index surgery
As defined by CDC
30 days from index surgery
Incidence of hematomas
Time Frame: 30 days from index surgery
As defined by CDC
30 days from index surgery
Incidence of major morbidities
Time Frame: 30 days from index surgery
Incidence of pancreatic fistula, hemorrhage, delayed gastric emptying, Clavien -Dindo morbidity
30 days from index surgery
Stony Brook Scar Evaluation Scale Score
Time Frame: 30 days after index surgery
The Stony Brook Evaluation Scale evaluate the aesthetic result of an incision. Score ranges from 0 (worst aesthetic result) to 5 (best aesthetic result)
30 days after index surgery

Collaborators and Investigators

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

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Collaborators

Smith & Nephew Wound Management Inc

Investigators

  • Principal Investigator: Luca Landoni, MD, AOVR Veneto

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 (ACTUAL)

July 25, 2018

Primary Completion (ACTUAL)

October 10, 2019

Study Completion (ACTUAL)

October 10, 2019

Study Registration Dates

First Submitted

May 15, 2018

First Submitted That Met QC Criteria

October 5, 2018

First Posted (ACTUAL)

October 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 8, 2020

Last Update Submitted That Met QC Criteria

May 6, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PICO (1215CESC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Surgical Site Infection

Clinical Trials on Disposable negative wound pressure device (PICO)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe