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

Primary Purpose

Surgical Site Infection

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Disposable negative wound pressure device (PICO)
OPsite post-op visible standard sterile dressing
Sponsored by
Azienda Ospedaliera Universitaria Integrata Verona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection focused on measuring negative pressure wound therapy, wound infection, pancreaticoduodenectomy, total pancreatectomy, surgical palliation of pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale Policlinico GB Rossi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Negative wound pressure device (PICO)

Standard sterile dressing

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Surgical Site Infection (non-organ space)
Superficial + deep surgical site infection as defined by CDC

Secondary Outcome Measures

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

Full Information

First Posted
May 15, 2018
Last Updated
May 6, 2020
Sponsor
Azienda Ospedaliera Universitaria Integrata Verona
Collaborators
Smith & Nephew Wound Management Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03700086
Brief Title
Efficacy of NPWT in Reducing the Incidence of Wound Infection After Pancreatic Surgery
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 25, 2018 (Actual)
Primary Completion Date
October 10, 2019 (Actual)
Study Completion Date
October 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda Ospedaliera Universitaria Integrata Verona
Collaborators
Smith & Nephew Wound Management Inc

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
negative pressure wound therapy, wound infection, pancreaticoduodenectomy, total pancreatectomy, surgical palliation of pancreatic cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Negative wound pressure device (PICO)
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard sterile dressing
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Disposable negative wound pressure device (PICO)
Intervention Description
Application of a disposable negative wound pressure device for surgical site infection prevention.
Intervention Type
Device
Intervention Name(s)
OPsite post-op visible standard sterile dressing
Intervention Description
Application of a standard sterile wound dressing.
Primary Outcome Measure Information:
Title
Surgical Site Infection (non-organ space)
Description
Superficial + deep surgical site infection as defined by CDC
Time Frame
30 days from index surgery
Secondary Outcome Measure Information:
Title
Rate of discontinuation of negative wound pressure therapy
Description
Discontinuation of therapy due to patient choice
Time Frame
7 days from index surgery
Title
Incidence of seromas
Description
As defined by CDC
Time Frame
30 days from index surgery
Title
Incidence of hematomas
Description
As defined by CDC
Time Frame
30 days from index surgery
Title
Incidence of major morbidities
Description
Incidence of pancreatic fistula, hemorrhage, delayed gastric emptying, Clavien -Dindo morbidity
Time Frame
30 days from index surgery
Title
Stony Brook Scar Evaluation Scale Score
Description
The Stony Brook Evaluation Scale evaluate the aesthetic result of an incision. Score ranges from 0 (worst aesthetic result) to 5 (best aesthetic result)
Time Frame
30 days after index surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Landoni, MD
Organizational Affiliation
AOVR Veneto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Policlinico GB Rossi
City
Verona
ZIP/Postal Code
37134
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
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Efficacy of NPWT in Reducing the Incidence of Wound Infection After Pancreatic Surgery

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