Surgical wound infection Infections and Infestations
Conditions
Interventions
Current intervention as of 17/09/2020:
Patients in the UK and Australia will be identified as possible participants by the surgical team as they are assessed during their admission to hospital. It is
Sponsors
University of Birmingham
University of Newcastle Australia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 17/09/2020: 1. All adults undergoing emergency (non-elective) laparotomy 2. Procedures with an incision of at least 5 cm 3. Operations where the skin is closed primarily 4. Patients aged at least 16 years 5. Patients able to provide informed consent, or consultee/representative provides assent/consent if a patient temporarily lacks capacity 6. Patients willing and able to undergo follow-up at 30 days post-op Previous participant inclusion criteria: All adults undergoing emergency laparotomy surgery for any surgical indication and via any abdominal incision >5 cm
Exclusion criteria
Exclusion criteria: 1. Aged less than 16 years 2. Permanent/long-term incapacity to consent 3. Procedures with an incision of less than 5 cm 4. Operations where the skin is not primarily closed 5. Abdominal surgery within the preceding 3 months 6. Patient unwilling or unable to attend follow-up visit at around 30 days post-operation 7. Expected return to theatre for reopening of laparotomy wound within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 17/09/2020: SSI as defined by CDC criteria within 30 days post-operatively. Direct wound assessment will be conducted on day 5-10 post-operation or on discharge (whichever is sooner) and at 30-44 days post-operation by a blinded and trained wound assessor. Wound dairies will also be consulted. _____ Previous primary outcome measure: SSI as defined by CDC criteria; Timepoint(s): Within 30 days post-operatively. Direct wound assessment will be conducted on day 5-7 post-operation or on discharge (whichever is sooner). It will also be performed at 30 days post-operation by a blinded and trained wound assessor. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 08/10/2021: 1. Length of hospital stay after surgery as measured from the date of index surgery to the date of discharge (this will be reported for UK patients only) 2. Wound complications as graded by Clavien-Dindo scale within 30 days post-surgery 3. Hospital re-admission for wound-related complications within 30 days. These will include SSIs, wound breakdown/dehiscence, seromas, and wound-related pain. 4. Health-related quality of life assessed using the validated Short Form-12 (SF-12) questionnaire at baseline, day 7, and day 30, and the EuroQol-5 Dimension-5 Level (EQ-5D-5L) at baseline, day 7, day 14, day 21, and day 30 5. Pain at the site of the primary laparotomy, assessed using a 10-point visual analogue scale of 1-10 at day 7 and day 30 6. Serious adverse events up to 30 days 7. Cost-effectiveness assessed using a patient diary for patient reported healthcare resource usage. Healthcare usage will be taken directly from the patient diaries and the costs attributable to this will be identified 8. Patient acceptability of use of their dressing via an acceptability score using a 10-point visual analogue scale of 1-10 at day 7, reflecting participant’s assessment of the acceptability of having the dressing 9. Health professional’s acceptability of use of SUNPD (via a survey of users in the UK only). This will focus on the ease of application of the dressing, the care needed to maintain/monitor the dressing while it is in place and an overall assessment of health professional’s experience of the dressing. Previous secondary outcome measures as of 17/09/2020: 1. Length of hospital stay after surgery as measured from the date of index surgery to the date of discharge 2. Wound complications as graded by Clavien-Dindo scale within 30 days post-surgery 3. Hospital re-admission for wound-related complications within 30 days. These will include SSIs, wound breakdown/dehiscence, seromas and wound-related pain. 4. Health-related | — |
Countries
Australia, England, Scotland, United Kingdom
Contacts
Public ContactJames Brown
Outcome results
None listed