Surgical Site Complications (SSC's) are responsible for increased morbidity in patients undergoing surgery resulting in prolonged length of stay in the hospital while increasing treatment and hospital costs dramatically. Negative Pressure Wound Therapy (NPWT) use on closed incisions has been reported in the literature to reduce SSC's including Surgical Site Infections (SSI's), with many promising studies in general surgery, including some studies using single use NPWT. However, to date, there are very few randomised controlled trials (RCT's) using this intervention. When using PICOTM (NPWT) for this indication, patients may be discharged from hospital earlier, with the negative pressure incision management in place. This has implications in terms of cost savings for the health care system and enables the patient to be able to return to their normal daily routine more quickly. The hypothesis of this study is that PICO NPWT will reduce frequency of SSC's, in a 30 day follow up period, as compared to standard care in patients undergoing colorectal procedures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
PICO is a Single-Use Negative Pressure Wound Therapy (NPWT) System consisting of a small portable pump, 2 lithium batteries, 2 dressings and fixation strips. The system is capable of delivering up to 80 mm Hg negative pressure to a wound or surgical incision site and managing low to moderate levels of exudate or fluid generated by the wound or incision. The therapy may be administered for up to 2 weeks.
Care path normally used by the hospital
Number of complications in each group
Time frame: 30 days
Dehiscence incidence during a 30-day follow-up period
Time frame: 30 days
Haematoma incidence during a 30-day follow-up period
Time frame: 30 days
Seroma incidence during a 30-day follow-up
Time frame: 30 days
Time to surgical incision closure
Time frame: 30 days
Total length of hospital stay, including readmissions during a 30-day follow-up period
Time frame: 30 days
Time to initial discharge during a 30-day follow-up period
Time frame: 30 days
Total number of readmissions during a 30-day follow-up period
Time frame: 30 days
To compare PICO against Standard Care for differences in Health Related Quality of Life (HRQoL) using SF-12 over the 14-day and 30-day follow-up period
Time frame: 30 days
Overall per subject treatment cost for PICO and Standard Care
Time frame: 30 days
Cost per Quality Adjusted Life Year (QALY) within a 30-day follow-up period
Time frame: 30 days
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