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WELCOME TO THE SUNRRISE TRIAL

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

What is SUNRRISE?

Primary Objective

Does the use of a single-use negative pressure dressing (SUNPD) in adult patients undergoing emergency laparotomy reduce surgical site infection at 30 days post-operatively compared to cases not using the device?

Trial Design

  • 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).

Key Eligibility Criteria

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 16 years
  • Patient able to provide informed consent, or consultee/representative provides assent/consent if a patient temporarily lacks capacity
  • Patients willing and able to attend follow-up at 30 days post-op
Exclusion Criteria
  • Abdominal surgery within the preceding three months from the date of randomisation
  • Expected return to theatre for reopening of the laparotomy wound within 30 days

Intervention

Patients are randomised between the intervention group (SUNPD) and control group (surgeon’s preference of dressing). The randomisation will take place in theatre using an online or telephone-based randomisation system following commencement of closure of skin. The SUNPD will remain in situ for 7 days or until discharge, whichever is earlier.

Outcome Measures

Primary outcome:
  • Surgical site infection within 30 days post-operation – as defined by the internationally accredited Centers for Disease Control (CDC) criteria.

Secondary outcomes:
  • Length of hospital stay after surgery
  • Wound complications as graded by the Clavien-Dindo scale
  • Hospital re-admission rate for wound related complication within 30 days
  • Health-related Quality of Life using Short Form-12 Health Survey (SF-12) and EuroQol-5 Dimension-5 Level (EQ-5D-5L)
  • Serious adverse events
  • Cost effectiveness
  • Patient acceptability
  • Health professional’s acceptability of use of SUNPD (via a survey of users at the end of the feasibility phase)

If you are not a SUNRRISE centre but are interesting in taking part, please contact the SUNRRISE Trial Office;

SUNRRISE@trials.bham.ac.uk

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