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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
100
Application of a disposable negative wound pressure device for surgical site infection prevention.
Application of a standard sterile wound dressing.
Ospedale Policlinico GB Rossi
Verona, Italy
Surgical Site Infection (non-organ space)
Superficial + deep surgical site infection as defined by CDC
Time frame: 30 days from index surgery
Rate of discontinuation of negative wound pressure therapy
Discontinuation of therapy due to patient choice
Time frame: 7 days from index surgery
Incidence of seromas
As defined by CDC
Time frame: 30 days from index surgery
Incidence of hematomas
As defined by CDC
Time frame: 30 days from index surgery
Incidence of major morbidities
Incidence of pancreatic fistula, hemorrhage, delayed gastric emptying, Clavien -Dindo morbidity
Time frame: 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)
Time frame: 30 days after index surgery
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