NCT03700086

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
DEVICE	Disposable negative wound pressure device (PICO)	Application of a disposable negative wound pressure device for surgical site infection prevention.
DEVICE	OPsite post-op visible standard sterile dressing	Application of a standard sterile wound dressing.

Timeline

• Start date: 2018-07-25
• Primary completion: 2019-10-10
• Completion: 2019-10-10
• First posted: 2018-10-09
• Last updated: 2020-05-08

Locations

1 site across 1 country: Italy