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
  • 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.

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 written 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