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

Australia and New Zealand Clinical Trials Registry Trial ID: ACTRN12619000496112

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 Single Use Negative Pressure Dressing (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 Centers for Disease Control and Prevention (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 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
      • systemic fever (>38°C).
      • heat
      • redness
      • localised swelling
    • 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
Trial Design
  • Pragmatic multi-centre, prospective, phase III, 2 arm, randomised controlled trial
  • 630 patients from the UK and 210 patients from Australia 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).

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 18 years
  • Patient able to provide informed consent
  • Patients willing and able to participate in 30 follow up in clinic or by video call

Exclusion Criteria

  • Abdominal surgery within the preceding three months from the date of randomisation
  • Expected return to theatre and opening of laparotomy wound within 30 days

Contact

Email: sunrriseaus@newcastle.edu.au

Phone: (02) 4923 6248

Address:
John Hunter Hospital
Surgical Services
Locked Bag No. 1, Hunter Region Mail Centre,
NSW 2310 Australia