Do suction assisted negative pressure dressings reduce the incidence of surgical site infections after abdominal surgery: a randomized controlled trial.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000175572
• Date of registration: 23/02/2015
• Prospective Registration: Yes
• Primary sponsor: Dandenong Campus, Monash Health
• Public title: Do suction assisted negative pressure dressings reduce the incidence of surgical site infections after abdominal surgery: a randomized controlled trial.
• Scientific title: Do suction assisted negative pressure dressings(NPD) reduce the incidence of surgical site infections after clean/contaminated abdominal surgery: a randomized controlled trial.
• Date of first enrolment: 23/03/2015
• Target sample size: 160
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12615000175572.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 2

Countries of recruitment

Australia

Contacts

• Name: Dr Julie Flynn

• Name: Dr Julie Flynn

Key inclusion & exclusion criteria

Inclusion criteria: * Patients undergoing laparotomy (where abdominal incision breaches peritoneum, and wound is large enough at least to fit the surgeons’ hand); and
* High risk for SSI, with one or more of the following risk factors:
* Obesity (BMI > 30)
* Contaminated surgery (perforation or abscess)
* Semi emergency clean/contaminated surgery (where surgery may be safely delayed up to 24 hours)
* Are able to read English, or have the consent form translated for them
* Are able to provide written informed consent

Exclusion criteria: * Mini laparotomy
* Elective clean surgery (Right Hemi colectomy, Anterior resection)
* Emergency ‘clean’ surgery, e.g. adhesiolysis, hernia repair, wound dehiscence
* Relook surgery
* Pregnant patients
* Patients under 18 years of age
* Patients who are unwilling or unable to consent
* Patient too sick to give informed consent- e.g. sepsis, or requiring urgent surgery within 24 hours of presentation to hospital


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Infection - Studies of infection and infectious agents

Laparotomy wound infection;
Laparotomy wound infection

Surgery - Other surgery

Intervention(s)

Negative-pressure wound dressing by Smith & Nephew called PICO.
PICO is a pocket sized portable device attached to laparotomy wound dressing via a long thin tubing.
The device is left switched on for 7 consecutive days with no further dressing change required. A negative pressure milieu of 80 mmHg (nominal) +/- 20 mmHg is applied to the wound surface.

Primary Outcome(s)

Wound infection - Definition based on definitions published by VICNISS, the major healthcare infection surveillance organisation for Victoria. This outcome is assesed by our research/stoma Nurses at Dandenong Hospital on day 7(up to day9) of having had surgery[7 days]

Secondary Outcome(s)

Patient satisfaction. Measured with satisfaction questionnaire on various aspect of patient's experience of his/her wound dressing. Satisfaction level graded on a linear scale from 1- to 10. This is completed over the phone at day 30 by researcher[30 days]

Secondary ID(s)

nil

Source(s) of Monetary Support

Smith and Nephew Medical Ltd

Secondary Sponsor(s)

P.Y Tan

J Flynn

Ethics review

Status: Approved
Approval date:
Contact:

Monash Health Human Research Ethics Committee