SUNRRISE

sunrrise logo

Single Use Negative pRessure dressing for Reduction ISurgical site infection following Emergency laparotomy

You can randomise patients 24 hours a day, 7 days a week by phone (0800 2802 307) or online (https://w3.abdn.ac.uk/hsru/SUNRRISE).

More details can be found below.

Rationale

Patients undergoing emergency laparotomy are at high risk of SSI and a reduction of SSI rates following emergency laparotomy will clinically benefit patients. There are no planned or ongoing trials assessing SUNPD in the context of emergency laparotomy.

Objectives

Primary objective:

  • To determine if the use of a SUNPD in adult patients undergoing emergency laparotomy reduces surgical site infection (SSI) at 30 days compared to surgeon’s preference of dressing (which may be conventional occlusive dressings, skin glue or no dressing).

Secondary objectives:

To determine if:

  • The use of SUNPD reduces length of hospital stay after surgery
  • The use of SUNPD reduces the rate of wound complications
  • The use of SUNPD reduces wound complication related hospital re-admission rates
  • The use of SUNPD improves health-related quality of life
  • The use of SUNPD is safe in this population
  • The use of SUNPD is acceptable to patients and healthcare professionals
  • The use of a SUNPD is cost-effective compared to the use of the surgeon’s preference of dressing

Comparison of a new method of diagnosis of SSI:

The current established method of diagnosing SSIs is using the CDC criteria. These criteria are used for the diagnosis of wound infections in this study. The use of CDC for diagnosing wound infections involves assessment of the wound by a health professional. A new tool for diagnosing wound infections (Bluebelle) has been developed that does not require a clinical assessment. This trial will allow the comparison of this tool with the in-person wound review assessment as per the CDC criteria.

Outcomes

Primary outcome:

 The primary outcome is SSI within 30 days of surgery, as defined by the internationally accredited CDC criteria. Direct wound assessment will be conducted on day 5-7 post-operation or on discharge (whichever is sooner). It will also be performed at 30 days post-operation, by a blinded and trained wound assessor. The intervening period will be covered by a structured patient diary.

The following CDC definition will be used to identify an SSI: 

  • The infection must occur within 30-days of the index operation

AND

  • The patient must have at least one of the following:
      • Purulent drainage from the wound
      • Organisms are detected from a wound swab
      • Wound opened spontaneously or by a clinician AND, at the surgical wound, the patient has at least one of:
            • pain or tenderness
            • localised swelling
            • redness
            • heat
            • systemic fever (>38°C).
      • Diagnosis of SSI by a clinician or on imaging

Secondary outcomes:

  • Length of hospital stay after surgery as measured from the date of surgery to the date of discharge
  • Wound complications within 30 days post-surgery as graded by Clavien-Dindo scale
  • Hospital re-admission for wound related complications within 30 days. These will include SSIs, wound breakdown/ dehiscence, seromas and wound related pain
  • Health-related Quality of Life assessed using the validated Short Form-12 (SF-12) questionnaire at baseline, and day 7 and day 30, and the EuroQol-5 Dimension-5 Level (EQ-5D-5L) at baseline, day 7, day 14, day 21 and day 30. Pain at the site of the primary laparotomy will also be assessed, using a Likert scale of 1-10 at day 7 and day 30
  • Serious adverse events up to 30 days
  • Cost-effectiveness assessed using a patient diary for patient reported healthcare resource usage. Healthcare usage will be taken directly from the patient diaries and the costs attributable to this will be identified
  • Patient acceptability of use of their dressing via an acceptability score using a Likert scale of 1-10 at day 7, reflecting participant’s assessment of the acceptability of having the dressing
  • Health professional’s acceptability of use of SUNPD (via a survey of users at the end of the feasibility phase). This will focus on the ease of application of the dressing, the care needed to maintain/monitor the dressing while it is in place and an overall assessment of health professional’s experience of the dressing

Trial Design

  • Pragmatic multi-centre, prospective, phase III, 2 arm, randomised controlled trial with internal feasibility study
  • 630 patients will be randomised in a 1:1 ratio between SUNPD and surgeon’s preference of dressings (which may be conventional occlusive dressings, skin glue or no dressing).

 Trial Schema (simple) v1.0 (21-Sep-18)

Eligibilty Criteria

Inclusion Criteria

  • Patients undergoing emergency (non-elective) laparotomy

Exclusion Criteria

  • Patients aged less than 16 years
  • Patients who are unable to provide consent due to long-term incapacity
  • Procedures with a planned incision of less than 5cm
  • Operations where the skin is not primarily closed
  • Abdominal surgery within the preceding three months from the date of randomisation
  • Patient unwilling or unable to attend follow-up at 30 days
  • Expected return to theatre and opening of laparotomy wound within 30 days

Training

The SUNRRISE trial involves several types of training:

  • Study-specific – this is provided by the SUNRRISE team during the Site Initiation Visit (SIV). It will be face-to-face whenever possible and ideally near the time of opening. Once open, further study-specific training (i.e. new staff) can be delivered via teleconference by SUNRRISE team or disseminated by the PI.
  • Dressing application training – this will be provided by Smith & Nephew representatives who will liaise directly with sites to arrange this. We will provide Smith & Nephew with the PIs contact details unless provided with alternate contact. Once open, dressing application training (i.e. new staff) is to be disseminated by the PI.

The above types of training must be completed before a site can open to recruitment

  • Wound-assessment training – this is delivered via an online module which is currently in development BUT will be available soon.

The above type of training must be completed by anyone who will be reviewing the wound of trial participants. 

Randomisation

If you are one of the SUNRRISE sites and are open to recruitment you can randomised 24 hours a day, 7 days a week. This can be done either by phone or online. The randomisation service is provided by the Centre for Healthcare Randomised Trials (CHaRT), located in the Health Services Research Unit (HSRU) at the University of Aberdeen.

Telephone Randomisation - call 0800 2802 307 

You will need to know your centre/site ID code and enter this at the start of the call - this will be available from your local PI and their team, and also from the SUNRRISE Trial Office.

Online Randomisation - visit https://w3.abdn.ac.uk/hsru/SUNRRISE

You will need to login using your unique usename, which can be obtained by contacting the SUNRRISE Trial Office.