None listed
Conditions
Brief summary
Sunrrise Australia is the Australian arm of the Sunrrise Trial (Single Use Negative pRessure dressing for Reduction In Surgical site infection following Emergency laparotomy), a randomised controlled trial funded by the Research for Patient Benefit Program of the National Institute of Health Research UK. The UK trial is led by the Trainee Research Collaboratives in the West Midlands and North West Regions of England. Sunrrise Australia has full support from NIHR RfPB board, the UK trial leaders and the Clinical Trials Network Australia and New Zealand (CTANZ) This study tests whether a new type of active wound dressing can reduce rates of wound infection (surgical site infection, ‘SSI’) after emergency surgery on the abdomen. These dressings are Single Use Negative Pressure Dressings (SUNPD). They combine a sealed pad and suction to remove fluid from in and around the wound. Emergency abdominal operations are performed for a variety of life-threatening reasons, including bowel blockages, perforations, traumatic injuries and infections. At least 1 in 4 patients will be affected by an SSI after these procedures. These SSIs are painful, take longer to heal, extend hospital stays, incur significant extra costs, and can lead to ongoing wound care in the community. In an already unwell patient, development of an SSI can contribute to other major complications, including death. The trial is currently recruiting patients at 5 sites in the UK. It is expected that a further 25 UK sites will be opened by December 2019. With support from this grant, Australian sites will start recruiting in October 2019 The Australian study increases the power from 80% to 90%, reinforces the links in Surgical Research that have developed between the Research Collaboratives in the UK and Australia, and enhances surgical clinical research capacity in Australia by training a new generation of surgical trainees in trial methodology and conduct.
Interventions
The intervention used in SUNRRISE is Single Use Negative Pressure Dressings (SUNPD). This is a foam pad which lies over the wound, covered with a semipermeable adhesive plastic membrane. A sealed tube connects the foam to an external pump, which creates a negative pressure gradient over the wound. This closed negative-pressure environment removes blood and serous fluid exuding from the wound. The SUNPD is put in place, in theatre, after wound closure and is left in situ for 7 days.
The interv
The intervention used in SUNRRISE is Single Use Negative Pressure Dressings (SUNPD). This is a foam pad which lies over the wound, covered with a semipermeable adhesive plastic membrane. A sealed tube connects the foam to an external pump, which creates a negative pressure gradient over the wound. This closed negative-pressure environment removes blood and serous fluid exuding from the wound. The SUNPD is put in place, in theatre, after wound closure and is left in situ for 7 days. The intervention and control dressings are put in place by the surgeon or the surgical registrar for each case. Observation charts are kept up to date on the ward.
Sponsors
The University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Patients undergoing emergency (non-elective) laparotomy -Procedures with a planned incision of at least 5cm -Operations where the skin is closed primarily -Patients aged at least 18 years -Patient able to provide written informed consent -Patients willing and able to undergo follow-up at 30 days post-op
Exclusion criteria
-Abdominal surgery within the preceding three months from the date of randomization -Expected return to theatre for reopening of the laparotomy wound within 30 days -Patients unable to provide informed consent and participate in English
Outcome results
None listed