Primary outcome:
The primary outcome is SSI within 30 days of surgery, as defined by the internationally accredited CDC criteria. Wound assessment will be conducted on day 7 post-operation or on discharge (whichever is sooner). It will also be performed at day 30 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 index 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
- In the UK only, health professional’s acceptability of use of SUNPD (via a survey of users). 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