Preventing abdominal surgical wound infections with negative pressure wound therapy dressings
| ISRCTN | ISRCTN43457163 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43457163 |
| Secondary identifying numbers | HREC/14/WMEAD/321 |
- Submission date
- 12/05/2020
- Registration date
- 22/05/2020
- Last edited
- 15/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Public
Lakeview Private Hospital
17/19 Solent Cct
Baulkham Hills
2153
Australia
| Phone | +61 (0)2 8711 0170 |
|---|---|
| gramatter.gc@gmail.com |
Scientific
Westmead Hospital
Cnr Hawkesbury and Darcy Rd
Westmead
2145
Australia
| Phone | +61 (0)8890 5555 |
|---|---|
| angelina.di-re@health.nsw.gov.au |
Study information
| Study design | Prospective non-blinded phase III multi-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Surgical Wound Infection Prevention by Early Intervention using Topical negative pressure therapy – the SWIPE IT trial |
| Study acronym | SWIPE IT |
| Study objectives | That negative pressure wound therapy (NPWT) dressings decrease the incidence of superficial surgical site infection (SSI). |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 26/07/2014 |
| Completion date | 31/10/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 178 |
| Total final enrolment | 127 |
| Key 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 |
| Key exclusion criteria | 1. Hypersensitivity to silver 2. Patients without capacity to consent, pregnancy 3. Patients with pre-existing laparostomy |
| Date of first enrolment | 14/10/2015 |
| Date of final enrolment | 05/07/2019 |
Locations
Countries of recruitment
- Australia
Study participating centres
Westmead
2145
Australia
Blacktown
2148
Australia
Sponsor information
Hospital/treatment centre
Corner Hawkesbury Road and Darcy Rd
Westmead
2145
Australia
| Phone | +61 (0)8890 5555 |
|---|---|
| WSLHD-ResearchOffice@health.nsw.gov.au | |
| Website | http://www.wslhd.health.nsw.gov.au/Westmead-Hospital/Westmead-Hospital |
"ROR" |
https://ror.org/04gp5yv64 |
Funders
Funder type
Hospital/treatment centre
No information available
No information available
Results and Publications
| Intention to publish date | 01/10/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Aim to publish this study in a peer-reviewed journal such as Surgery or ANZ Journal of Surgery. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version V02 | 20/10/2014 | 08/06/2020 | No | No |
| Results article | 15/11/2021 | 15/11/2021 | Yes | No |
Additional files
- ISRCTN43457163_PROTOCOL_V02_20Oct14.pdf
- Uploaded 08/06/2020
Editorial Notes
15/11/2021: Publication reference added.
08/06/2020: Uploaded protocol version 2.0, 20 October 2014 (not peer reviewed).
20/05/2020: Trial's existence confirmed by Western Sydney Local Health District Ethics Committee.
