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Efficacy of a Disposable Negative Wound Pressure Device in Reducing the Incidence of Wound Infection After HPB Surgery

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ClinicalTrials.gov Identifier: NCT03700086
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : October 9, 2018
Sponsor:
Collaborator:
Smith & Nephew Wound Management Inc
Information provided by (Responsible Party):
Azienda Ospedaliera Universitaria Integrata Verona

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.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Device: Disposable negative wound pressure device (PICO) Device: OPsite post-op visible standard sterile dressing Not Applicable

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. HPB procedures like pancreaticoduodenectomy (PD), total pancreatectomy (TP) and palliative procedures like gastric by-pass and hepaticojejunostomy GEA/HJ) are considered as clean-contaminated procedures 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 HPB surgery.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of a Disposable Negative Wound Pressure Device in Reducing the Incidence of Wound Infection After HPB Surgery: a Pilot Randomized Controlled Trial
Actual Study Start Date : September 30, 2018
Estimated Primary Completion Date : May 10, 2019
Estimated Study Completion Date : June 10, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Surgical Site Infection [ Time Frame: 30 days from index surgery ]
    Superficial + deep surgical site infection as defined by CDC


Secondary Outcome Measures :
  1. Rate of discontinuation of negative wound pressure therapy [ Time Frame: 7 days from index surgery ]
    Discontinuation of therapy due to patient choice

  2. Incidence of seromas [ Time Frame: 30 days from index surgery ]
    As defined by CDC

  3. Incidence of hematomas [ Time Frame: 30 days from index surgery ]
    As defined by CDC

  4. Incidence of major morbidities [ Time Frame: 30 days from index surgery ]
    Incidence of pancreatic fistula, hemorrhage, delayed gastric emptying, Clavien -Dindo morbidity

  5. 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)

  6. Costs [ Time Frame: 30 days after index surgery ]
    calculated on the basis of the daily cost per device multiplied by the days of hospital stay



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700086


Contacts
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Contact: Luca Landoni, MD 00390458124553 luca.landoni@aovr.veneto.it
Contact: Claudio Bassi, MD 00390458124553 claudio.bassi@univr.it

Locations
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Italy
Ospedale Policlinico GB Rossi Recruiting
Verona, Italy, 37134
Contact: Luca Landoni, MD    0458124553 ext 0039    luca.landoni@aovr.veneto.it   
Principal Investigator: Claudio Bassi, MD         
Principal Investigator: Luca Landoni, MD         
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Integrata Verona
Smith & Nephew Wound Management Inc
Investigators
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Principal Investigator: Luca Landoni, MD AOVR Veneto

Publications of Results:

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Responsible Party: Azienda Ospedaliera Universitaria Integrata Verona
ClinicalTrials.gov Identifier: NCT03700086     History of Changes
Other Study ID Numbers: PICO
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Azienda Ospedaliera Universitaria Integrata Verona:
negative pressure wound therapy
wound infection
pancreaticoduodenectomy
total pancreatectomy
surgical palliation of pancreatic cancer

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes