Clinical trial NCT03700086: 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
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Keywords: negative pressure wound therapy
wound infection
pancreaticoduodenectomy
total pancreatectomy
surgical palliation of pancreatic cancer
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
Collaborators: name: Smith & Nephew Wound Management Inc
First posted: 2018-10-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomized controlled trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Surgical Site Infection (non-organ space)
timeFrame: 30 days from index surgery
Secondary outcomes:
measure: Rate of discontinuation of negative wound pressure therapy
timeFrame: 7 days from index surgery
measure: Incidence of seromas
timeFrame: 30 days from index surgery
measure: Incidence of hematomas
timeFrame: 30 days from index surgery
measure: Incidence of major morbidities
timeFrame: 30 days from index surgery
measure: Stony Brook Scar Evaluation Scale Score
timeFrame: 30 days after index surgery
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Ospedale Policlinico GB Rossi
Study officials:
affiliation: AOVR Veneto
name: Luca Landoni, MD
role: PRINCIPAL_INVESTIGATOR
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