Preventing abdominal surgical wound infections with negative pressure wound therapy dressings

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN43457163

Enrollment

178

Registered

2020-05-22

Start date

2015-10-14

Completion date

Unknown

Last updated

2021-11-29

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

Conditions

Superficial surgical site infection Infections and Infestations

Interventions

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 ava

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Australia

Contacts

Public ContactGrahame Ctercteko

gramatter.gc@gmail.com+61 (0)2 8711 0170

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026