The objectives of the SUNRRISE study are to determine:
- If there is difference in wound infection rates in patients who receive portable single-use negative pressure dressings (SUNPD) compared to standard dressings.
- If there is any difference in the length of hospital stay, use of antibiotics, and total length of medical intervention between those patients who did and did not receive the negative pressure dressing
- Patient acceptability of the dressings
- Total intervention cost.
Surgical site infection (SSI) is a common post-operative complication and is the most common hospital acquired infection after urinary tract and respiratory tract infection(1). Data from the most recently published studies has demonstrated SSI occurs following laparotomy in up to 24% of cases, with rates of up to 30% in studies of emergency colorectal surgery (3). The development of an SSI is associated with significantly increased length of hospital stay and results in elevated healthcare costs as well as having a detrimental effect on patient satisfaction and health related quality of life.
Recognition of the clinical and health-economic and impact of SSI in the United Kingdom has resulted in prioririsation of evidence based measures to reduce the incidence of SSI as described in the National Institute of Health Care and Excellence (NICE) guideline CG74 and Quality Standard QS49. These measures include timely administration of prophylactic antibiotics, skin preparation with aqueous or alcohol based antiseptic, avoidance of inadvertent peri-operative hypothermia and maintenance of perioperative oxygenation >95%.
Negative pressure wound therapy (NPWT) has been used since the mid-1990s to manage and promote healing in chronic open wounds. More recently, evidence has emerged that NPWT may reduce complications when applied to closed incisions (7) (8), and has been recommended for use on closed sternotomy wounds to reduce the incidence of wound infection in high risk patients. However, traditional NPWT devices are large and cumbersome, and required specialist training for application associated with significant extra cost. There is some evidence from small observational studies that new small, highly portable single-use negative pressure dressings (SUNPD) can deliver NPWT. Such devices may be able to deliver NPWT at a lower overall cost and with greater patient acceptability compared to traditional NPWT devices. A recent Cochrane systematic review of NPWT highlighted the paucity of evidence in this area and recommended that the effects of the newer NPWT products designed for use on clean, closed surgical incisions be assessed urgently by suitably powered, high-quality trials.
Patients undergoing emergency laparotomy are at high risk of developing surgical site infection and therefore effective measures to reduce SSI incidence in this population would have a significant clinical and health economic impact. To date, there have been no randomised controlled trials assessing the use of SUNPDs in this context. We propose to perform a multi-centre, randomised controlled trial to investigate whether SUNPD can reduce the incidence of SSI following emergency laparotomy, compared to standard wound dressings.
The North West Research Collaborative (NWRC) and the West Midlands Research Collaborative (WMRC) are trainee-led surgical research networks within the North West and West Midlands respectively, established to promote trainee involvement in research. Trainee research collaboratives are ideally placed to facilitate multi-centre studies as the membership includes trainees placed at multiple sites across the deanery. This study will be run across multiple hospitals sites in the North West and West Midlands through the collaboration of NWRC and WMRC members with the support of local consultants at participating centres. Study co-ordination will undertaken collaboratively between the Birmingham and Liverpool clinical trials units.
We have been successfully awarded funding from the National Institute for Health Research (NIHR) research for patient benefit (RfPB) competition.
Contributors (North West):
Clinical lead and chief investigator
Mrs Sarah Duff
Consultant General and Colorectal surgeon
University Hospital of South Manchester
Senior statistician, Liverpool Clinical Trials Unit, Protocol Development Group
Northwest Research Collaborative Steering committee:
Mr Hamish Clouston, Specialty Trainee, North West Deanery
Ms Rebecca Fish, Specialty Trainee, North West Deanery
Ms Hema Sekhar, Specialty Trainee, North West Deanery
Mr Martyn Stott, Specialty Trainee, North West Deanery
Mr Peter Coe, Specialty Trainee, North West Deanery