Condition category
Infections and Infestations
Date applied
12/05/2020
Date assigned
22/05/2020
Last edited
21/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Surgical site infections (SSIs) are the most common cause of healthcare-associated infections in patients undergoing surgery. SSIs also contribute to increased morbidity, mortality, prolonged hospitalisation, impaired quality of life, and increased healthcare costs. It is unclear whether topical negative pressure wound therapy (NPWT) dressings can reduce the risk of SSIs in patients undergoing abdominal surgery. The aim of this study is to assess the effectiveness of NPWT at reducing superficial SSI following open abdominal surgery.

Who can participate?
Patients aged 16 years and over who are undergoing an “open” abdominal operation (a larger abdominal cut than smaller “keyhole” surgery)

What does the study involve?
Patients will be randomly allocated to receive either a “standard” dressing (a large “band-aid” covered simple dressing) or a negative pressure wound therapy dressing after surgery. This dressing will remain in place until days 5-7 post-surgery, after which it will then be removed. The total follow-up is for 30 days after surgery.

What are the possible benefits and risks of participating?
Patients with a silver allergy will not be eligible to participate in the study, as there is silver within the NPWT dressing. A benefit of participating may be determining whether NPWT does actually decrease the incidence of SSIs.

Where is the study run from
Blacktown and Westmead Public Hospitals (Australia)

When is the study starting and how long is it expected to run for?
July 2014 to October 2020

Who is funding the study?
The NPWT dressings and devices were provided by KCI Medical. There is no other funding received for this study.

Who is the main contact?
Dr Grahame Ctercteko
gramatter.gc@gmail.com

Trial website

Contact information

Type

Public

Primary contact

Dr Grahame Ctercteko

ORCID ID

Contact details

Lakeview Private Hospital
17/19 Solent Cct
Baulkham Hills
2153
Australia
+61 (0)2 8711 0170
gramatter.gc@gmail.com

Type

Scientific

Additional contact

Dr Angelina Di Re

ORCID ID

Contact details

Westmead Hospital
Cnr Hawkesbury and Darcy Rd
Westmead
2145
Australia
+61 (0)8890 5555
angelina.di-re@health.nsw.gov.au

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

HREC/14/WMEAD/321

Study information

Scientific title

Surgical Wound Infection Prevention by Early Intervention using Topical negative pressure therapy – the SWIPE IT trial

Acronym

SWIPE IT

Study hypothesis

That negative pressure wound therapy (NPWT) dressings decrease the incidence of superficial surgical site infection (SSI).

Ethics approval

Approved 17/07/2015, Western Sydney Local Health District Ethics Committee (Research & Education Network Building, Westmead Hospital, Cnr Hawkesbury Rd and Darcy Rd, Westmead, NSW, 2145, Australia; +612 (0)8890 8249; wslhd-researchoffice@health.nsw.gov.au), ref: HREC/14/WMEAD/321

Study design

Prospective non-blinded phase III multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Superficial surgical site infection

Intervention

Computer-assisted randomisation was used to assign patients to either the control (standard dressing) or interventional arm (NPWT) in a 1:1 allocation scheme. The outcome of randomisation was made available to the operating surgeon upon skin closure to avoid performance bias. Patients and study investigators were not blinded to the study intervention.

After skin closure, patients in the intervention arm had an NPWT (Prevena) dressing placed over the entire incision, with a pre-set negative pressure of 125 mmHg.

Patients in the control group had either a Cutiplast or Comfeel dressing placed covering the entire wound.

These dressings were left in place until days 5-7 post-operatively (at which time they were then removed).

Intervention type

Device

Phase

Phase III

Drug names

Primary outcome measure

The incidence of superficial SSI diagnosed on the basis of the following CDC criteria:
1. Purulent drainage, with or without laboratory confirmation, from within the wound
2. Organisms isolated from an aseptically obtained culture of fluid from the incision
3. At least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness and superficial incision deliberately opened by the surgeon, unless incision is culture-negative
4. Diagnosis of superficial incisional SSI by the independent assessor
Assessed by the treating doctors on postoperative day 5-7 and then on day 30

Secondary outcome measures

1. Deep and organ space SSI as measured by Centre for Disease Control and Prevention Surgical Site Infection criteria at Days 7 and 30 post-surgery (Deep = Infection involves deep tissues, such as fascial and muscle layers; Organ space = infection involves any part of the anatomy in organs and spaces other than the incision, which was opened or manipulated during operation)
2. Length of stay post-operatively, measured in days from date of hospital admission to date of hospital discharge
3. Fascial wound dehiscence, measured by fascial breakdown at Days 7 and 30 post-surgery (either a relook surgery or on imaging)
4. Superficial wound dehiscence, defined as any separation of the skin not associated with an SSI, at Days 7 and 30 post-surgery
5. Seroma: presence of serous fluid in the surgical wound either upon physical exam or on imaging, assessed at Days 7 and 30 post-surgery
6. Haematoma: presence of blood-stained fluid in the surgical wound either upon physical exam or on imaging, assessed at Days 7 and 30 post-surgery

Overall trial start date

26/07/2014

Overall trial end date

31/10/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age 16 years or over
2. Any gender
3. Undergoing elective or emergency laparotomy
4. All general surgical sub-disciplines were potentially included in the study
5. Patients undergoing minimally invasive surgery converted to laparotomy were also included

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

178

Total final enrolment

127

Participant exclusion criteria

1. Hypersensitivity to silver
2. Patients without capacity to consent, pregnancy
3. Patients with pre-existing laparostomy

Recruitment start date

14/10/2015

Recruitment end date

05/07/2019

Locations

Countries of recruitment

Australia

Trial participating centre

Westmead Hospital
Corner Hawkesbury Road and Darcy Road
Westmead
2145
Australia

Trial participating centre

Blacktown Hospital
18 Blacktown Road
Blacktown
2148
Australia

Sponsor information

Organisation

Westmead Hospital

Sponsor details

Corner Hawkesbury Road and Darcy Rd
Westmead
2145
Australia
+61 (0)8890 5555
WSLHD-ResearchOffice@health.nsw.gov.au

Sponsor type

Hospital/treatment centre

Website

http://www.wslhd.health.nsw.gov.au/Westmead-Hospital/Westmead-Hospital

Funders

Funder type

Hospital/treatment centre

Funder name

Westmead and Blacktown Hospitals

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

KCI (providing the NWPT dressings/devices)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Aim to publish this study in a peer-reviewed journal such as Surgery or ANZ Journal of Surgery.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Angelina Di Re (Angelina.dire@gmail.com). Data is currently available as a de-identified coded excel spreadsheet. It will be available for 5 years post study publication in a peer-reviewed journal. Data may be shared to scientific researchers, but this will need to first be approved by the Western Sydney Local Health District Ethics Committee, as specific patient consent for this has not been specifically obtained.

Intention to publish date

01/10/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

20/05/2020: Trial's existence confirmed by Western Sydney Local Health District Ethics Committee.