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

Do suction assisted negative pressure dressings(NPD) reduce the incidence of surgical site infections after clean/contaminated abdominal surgery: a randomized controlled trial.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000175572

Enrollment

188

Registered

2015-02-23

Start date

2015-03-23

Completion date

2017-09-15

Last updated

2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this project is to assess a new kind of dressing, to see whether it reduces the rate of wound infections after abdominal surgery. The dressing is attached to a small, portable device that creates suction or negative pressure on the wound, to help suck away any fluid that leaks from the wound. These dressings have been assessed as being safe, and are already in use in the hospital. However, there is no conclusive evidence that they provide a benefit to patients by reducing wound infections. We will hopefully answer that question, and help to provide better outcomes to future patients undergoing abdominal surgery. This study is in part funded by the company that makes the dressing used. However, they do not provide any direct payment to the investigators, and do not have any role in collecting information or deciding what the results of the study are. This research is being conducted by doctors and nurses working in Dandenong Hospital, under the auspices of the Monash School of Medicine.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results