Single use negative pressure dressing for reduction in surgical site infection following emergency laparotomy
| ISRCTN | ISRCTN17599457 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17599457 |
| Secondary identifying numbers | CPMS 36516, ACTRN12619000496112 |
- Submission date
- 24/09/2018
- Registration date
- 28/09/2018
- Last edited
- 28/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Emergency abdominal operations are performed for a variety of life threatening indications, including bowel blockages or perforations, traumatic injuries and major infections. Patients are left with large wounds on the abdomen, at least 1 in 4 of which will become infected. These surgical site infections (SSIs) are painful and take longer to heal, often resulting in a longer hospital stay and greater need for further wound care in the community. In an already unwell patient, development of an SSI can contribute to other major medical complications or even death. Single use negative pressure dressings (SUNPDs) are a special type of closed wound dressing that have recently been developed. They provide gentle suction to the closed wound and may help prevent development of an SSI. Negative pressure dressings are already used for some types of wounds and have been proven to be safe. However, they are more expensive so we need to be sure that that they are effective in reducing SSI before widespread uptake can be recommended within the NHS. This study aims to test whether the use of SUNPDs can reduce rates of SSI after emergency surgery on the abdomen.
Who can participate?
Patients aged 16 and over undergoing emergency abdominal operations
What does the study involve?
Participants are randomly allocated to receive either the new SUNPD dressings or standard dressings to establish whether they are effective in reducing SSI rates. The number of SSIs and the overall costs of treatment are compared between the two groups and the acceptability of the dressings to both patients and health professionals is assessed.
What are the possible benefits and risks of participating?
There are no guaranteed direct benefits involved with participating in this study but the SUNPD dressings could be shown to be more effective than standard dressings in preventing wound infections. The risks associated with the SUNPD dressing are the same as with any dressing after surgery. There is a small risk of a skin reaction or allergy to the dressing, which might cause redness, itching, swelling or pain over the skin next to the dressing. No other risks are known.
Where is the study run from?
University of Birmingham (UK)
When is the study starting and how long is it expected to run for?
November 2017 to August 2021 (updated 21/01/2021, previously: July 2021)
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
James Brown, sunrrise@trials.bham.ac.uk
Contact information
Scientific
Birmingham Clinical Trials Unit
The University of Birmingham
Birmingham
B15 2TT
United Kingdom
 ORCID ID |
0000-0001-5459-3962 |
|---|---|
| r.wilkin@bham.ac.uk |
Public
Birmingham Clinical Trials Unit
Public Health Building
University of Birmingham
Birmingham
B29 2TT
United Kingdom
| ORCID ID |
0000-0003-4513-1509 |
|---|---|
| Phone | +44 (0)121 414 9012 |
| sunrrise@trials.bham.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Device |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Single Use Negative pRessure dressing for Reduction In Surgical site infection following Emergency laparotomy |
| Study acronym | SUNRRISE |
| Study objectives | This study aims to test whether the use of a new type of active wound dressing (Single Use Negative Pressure Dressings ‘SUNPDs’) can reduce rates of wound infection (also called surgical site infection or ‘SSI’) after emergency surgery on the abdomen. |
| Ethics approval(s) | 1. Yorkshire & The Humber - Bradford Leeds Research Ethics Committee, 17/09/2018, ref: 18/YH/0322 2. Scotland A Research Ethics Committee, 10/07/2019, ref: 19/SS/0065 3. South Western Sydney Local Health District HREC, 01/03/2019, ref: SWS HREC EC00265 |
| Health condition(s) or problem(s) studied | Surgical wound infection |
| Intervention | 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 likely to be the surgical registrar that identifies the patient but it may be any member of the surgical team from Foundation Year 1 doctor to Consultant. The patient will be approached at the time that the decision to operate is made. Patients will be given a Patient Information Sheet and the trial will be discussed with them. The dressings will be fully explained and the patient will be given plenty of opportunity to ask questions. The principle of the dressings is simple to understand and our patient focus group believes that patients will be able to understand the trial concept despite the acute nature of their illness and impending surgery. If the patient agrees to participate in the trial, they will be asked to sign a consent form. They will then undergo an operation as decided by the clinical team. The involvement in this research will have no bearing on the choice or method of operation. As long as the patient fulfils the inclusion criteria, the patient will be randomised to either a SUNPD or a standard dressing at the end of the operation. It is important that this randomisation occurs once the skin has started to be closed. This is to prevent a change in the method of skin closure once it is known which arm the patient is going to be allocated to. When the skin is closed, either a standard dressing or a SUNPD will be applied. Patients will then undergo their normal pathway of care with no change in usual practice until post-operative day 7 or discharge (whichever is earlier) when the SUNPD will be removed and replace with a standard dressing. The wound will be assessed for the presence of a surgical site infection at 5-10 days or discharge after their operation or discharge (whichever is earlier). Upon discharge, the patient will be asked to complete a wound diary. This is a simple, tick box sheet that the patient will fill in each day. Every 7 days the diary contains the EQ-5D-5L questionnaire for the patient to fill in. To aid the patient in filling out the diary they will be contacted once a week (by telephone or text) by the research team to remind the patient to fill in the diary and also to provide help if needed in filling it out. The patient will be asked to undergo a wound review at 30-44 days after their operation for a wound review. This will be by a member of the research team that does not know if the patient had a SUNPD dressing or a standard dressing applied after their operation. The researcher will inspect the wound and ask the patient a few simple questions. If the wound has healed, the patient will have completed their involvement in the trial. If the patient has a wound that has not fully healed, they will be asked to continue in the trial. If they agree, they will be given a new wound diary and asked to complete until their wound has healed. They do not need to return for another wound check. _____ Previous intervention: Patients will be identified as possible participants by the surgical team as they are assessed during their admission to hospital. It is likely to be the surgical registrar that identifies the patient but it may be any member of the surgical team from Foundation Year 1 doctor to Consultant. The patient will be approached at the time that the decision to operate is made. Patients will be given a Patient Information Sheet and the trial will be discussed with them. The dressings will be fully explained and the patient will be given plenty of opportunity to ask questions. The principle of the dressings is simple to understand and our patient focus group believes that patients will be able to understand the trial concept despite the acute nature of their illness and impending surgery. If the patient agrees to participate in the trial, they will be asked to sign a consent form. They will then undergo an operation as decided by the clinical team. The involvement in this research will have no bearing on the choice or method of operation. As long as the patient fulfils the inclusion criteria, the patient will be randomised to either a SUNPD or a standard dressing at the end of the operation. It is important that this randomisation occurs once the skin has started to be closed. This is to prevent a change in the method of skin closure once it is known which arm the patient is going to be allocated to. When the skin is closed, either a standard dressing or a SUNPD will be applied. Patients will then undergo their normal pathway of care with no change in usual practice until post-operative day 7 or discharge (whichever is earlier). At this timepoint, the dressing will be removed and the wound will be assessed for the presence of a surgical site infection. Upon discharge, the patient will be asked to complete a wound diary (See supporting information/documentation). This is a simple, tick box sheet that the patient will fill in each day. Every seven days the diary contains the EQ-5D-5L questionnaire for the patient to fill in. To aid the patient in filling out the diary they will be contacted once a week (by telephone or text) by the research team to remind the patient to fill in the diary and also to provide help if needed in filling it out. The patient will be asked to return to hospital 30-37 days after their operation for a wound review. This will be by a member of the research team that does not know if the patient had a SUNPD dressing or a standard dressing applied after their operation. The researcher will inspect the wound and ask the patient a few simple questions. If the wound has healed, the patient will have completed their involvement in the trial. If the patient has a wound that has not fully healed, they will be asked to continue in the trial. If they agree, they will be given a new wound diary and asked to complete until their wound has healed. They do not need to return for another wound check. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 outcome measures | 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 quality of life assessed using the validated Short Form-12 (SF-12) questionnaire at baseline, and 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 Likert 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 Likert 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: 1. Length of hospital stay after surgery as measured from the date of 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 quality of life assessed using the validated Short Form-12 (SF-12) questionnaire at baseline, and 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 Likert 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 Likert 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 at the end of the feasibility phase). 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. |
| Overall study start date | 01/11/2017 |
| Completion date | 31/08/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 840; UK Sample Size: 520, AUS Sample Size: 320 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2018 |
| Date of final enrolment | 31/03/2021 |
Locations
Countries of recruitment
- Australia
- England
- Scotland
- United Kingdom
Study participating centres
Birmingham
B15 2WB
United Kingdom
Birmingham
B9 5ST
United Kingdom
Sandwell
B71 4HJ
United Kingdom
Stockport
SK2 7JE
United Kingdom
Manchester
M23 9LT
United Kingdom
Manchester
M13 9WL
United Kingdom
Bolton
BL4 0JR
United Kingdom
Salford
M6 8HD
United Kingdom
Coventry
CV2 2DX
United Kingdom
Wolverhampton
WV10 0QP
United Kingdom
Macclesfield
SK10 3BL
United Kingdom
Sheffield
S5 7AU
United Kingdom
Blackpool
FY3 8NR
United Kingdom
Ipswich
CO4 5JL
United Kingdom
Nottingham
NG7 2UH
United Kingdom
Dorchester
DT1 2JY
United Kingdom
Leicester
LE1 5WW
United Kingdom
Blackburn
BB10 2PQ
United Kingdom
Norwich
NR4 7UY
United Kingdom
Warwick
CV34 5BW
United Kingdom
Peterborough
PE3 9GZ
United Kingdom
Aberdeen
Foresterhill Road
United Kingdom
Paisley
PA2 9PN
United Kingdom
New Lambton Heights
Newcastle
NSW 2305
Australia
Sponsor information
University/education
Dr Birgit Whitman
Head of Research Governance and Integrity
Research Support
Birmingham
B15 2TT
England
United Kingdom
| Phone | +44 (0)121 414 7618 |
|---|---|
| researchgovernance@contacts.bham.ac.uk | |
"ROR" |
https://ror.org/03angcq70 |
University/education
University Drive
Callaghan
Newcastle
NSW 2308
Australia
| researchintegrity@newcastle.edu.au | |
| Website | http://www.newcastle.edu.au/ |
Funders
Funder type
Government
No information available
No information available
Results and Publications
| Intention to publish date | 31/07/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan as of 17/09/2020: The protocol will be made available on the SUNRRISE website (https://www.birmingham.ac.uk/SUNRRISE/). The findings will be published in international medical journals so that they can help patients globally, with links to publications available on the SUNRRISE website.# |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Laura Magill (e.l.magill@bham.ac.uk) and James Brown (j.p.brown.1@bham.ac.uk). Access to available anonymised data may be granted following review. _____ Previous publication and dissemination plan: The PIS and protocol will be made available on the SUNRRISE website (https://www.birmingham.ac.uk/research/activity/mds/trials/bctu/trials/coloproctology/SUNRRISE/investigators/documentation/docs-existingcentres.aspx) once the website is live and they have been approved. The findings will be published in international medical journals so that they can help patients globally. IPD sharing statement The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Laura Magill (e.l.magill@bham.ac.uk). Access to available anonymised data may be granted following review. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 04/12/2020 | 21/01/2021 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 27/01/2025 | 28/01/2025 | Yes | No |
Editorial Notes
28/01/2025: Publication reference added.
08/10/2021: The secondary outcome measures have been updated.
21/01/2021: The following changes were made to the trial record:
1. The overall end date was changed from 31/07/2021 to 31/08/2021.
2. The recruitment end date was changed from 31/12/2020 to 31/03/2021.
3. The plain English summary was updated to reflect these changes.
4. Publication reference added.
23/09/2020: The target number of participants has been changed from "Planned Sample Size: 940; UK Sample Size: 520, AUS Sample Size: 420" to "Planned Sample Size: 840; UK Sample Size: 520, AUS Sample Size: 320" and the total target enrolment from 940 to 840.
17/09/2020: The following changes have been made:
1. The trial website url has been changed.
2. The scientific contact has changed.
3. The public contact has been added.
4. Scotland A Research Ethics Committee has been added to the ethics approval list.
5. The intervention has been changed.
6. The primary outcome measure has been changed.
7. The secondary outcome measure has been changed.
8. The participant inclusion criteria have been changed.
9. The recruitment end date has been changed from 31/07/2020 to 31/12/2020.
10. Australia has been added to the countries of recruitment.
11. The sponsor contact details have been updated.
12. The publication and dissemination plan has been changed.
13. The University of Newcastle, Australia has been added as a sponsor.
14. The Australian National Health and Medical Research Council has been added as a funder.
15. The ANZCTR registration number ACTRN12619000496112 has been added to the protocol/serial number field.
16. New Cross Hospital, Macclesfield District General Hospital, Northern General Hospital, Blackpool Victoria Hospital, Ipswich Hospital, Queen's Medical Centre, Dorset County Hospital, Leicester Royal Infirmary, Royal Blackburn Teaching Hospital, Norfolk and Norwich University Hospital, Warwick Hospital, Peterborough City Hospital, Aberdeen Royal Infirmary, Royal Alexandra Hospital and John Hunter Hospital have been added to the trial partipating centres.
17. The plain English summary has been updated to reflect the above changes.
18. The target number of participants has been changed from "Planned Sample Size: 630; UK Sample Size: 630" to "Planned Sample Size: 940; UK Sample Size: 520, AUS Sample Size: 420" and the total target enrolment from 630 to 940.
16/09/2020: Recruitment has resumed.
16/04/2020: Due to current public health guidance, recruitment for this study has been paused.
02/10/2019: Internal review.
28/03/2019: The condition has been changed from "Specialty: Surgery, Primary sub-specialty: Trauma and Emergency Surgery; Health Category: Infection, Oral and Gastrointestinal; Disease/Condition: Bacterial, viral and other infectious agents" to "Surgical wound infection" following a request from the NIHR.
