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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Device: Disposable negative wound pressure device (PICO)
* Device: OPsite post-op visible standard sterile dressing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Negative wound pressure device (PICO)<br>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)<br>* Application of a disposable negative wound pressure device for surgical site infection prevention.<br>|
| Active Comparator: Standard sterile dressing<br>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<br>* Application of a standard sterile wound dressing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Site Infection (non-organ space) | 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 | Discontinuation of therapy due to patient choice | 7 days from index surgery | 
| Incidence of seromas | As defined by CDC | 30 days from index surgery | 
| Incidence of hematomas | As defined by CDC | 30 days from index surgery | 
| Incidence of major morbidities | Incidence of pancreatic fistula, hemorrhage, delayed gastric emptying, Clavien -Dindo morbidity | 30 days from index surgery | 
| 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) | 30 days after index surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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negative pressure wound therapy, wound infection, pancreaticoduodenectomy, total pancreatectomy, surgical palliation of pancreatic cancer