Condition category
Infections and Infestations
Date applied
24/09/2018
Date assigned
28/09/2018
Last edited
23/09/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 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

Trial website

https://www.birmingham.ac.uk/SUNRRISE/

Contact information

Type

Scientific

Primary contact

Mr Richard Wilkin

ORCID ID

http://orcid.org/0000-0001-5459-3962

Contact details

Birmingham Clinical Trials Unit
The University of Birmingham
Birmingham
B15 2TT
United Kingdom
-
r.wilkin@bham.ac.uk

Type

Public

Additional contact

Mr James Brown

ORCID ID

http://orcid.org/0000-0003-4513-1509

Contact details

Birmingham Clinical Trials Unit
Public Health Building
University of Birmingham
Birmingham
B29 2TT
United Kingdom
+44 (0)121 414 9012
sunrrise@trials.bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CPMS 36516, ACTRN12619000496112

Study information

Scientific title

Single Use Negative pRessure dressing for Reduction In Surgical site infection following Emergency laparotomy

Acronym

SUNRRISE

Study hypothesis

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

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

Study design

Randomised; Interventional; Design type: Treatment, Device

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

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

Phase

Drug names

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 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 trial start date

01/11/2017

Overall trial end date

31/07/2021

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 840; UK Sample Size: 520, AUS Sample Size: 320

Participant 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

Recruitment start date

01/11/2018

Recruitment end date

31/12/2020

Locations

Countries of recruitment

Australia, United Kingdom

Trial participating centre

Queen Elizabeth Hospital Birmingham
Mindelsohn Way
Birmingham
B15 2WB
United Kingdom

Trial participating centre

Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5ST
United Kingdom

Trial participating centre

Sandwell General Hospital
Lyndon
Sandwell
B71 4HJ
United Kingdom

Trial participating centre

Stepping Hill Hospital
Poplar Grove
Stockport
SK2 7JE
United Kingdom

Trial participating centre

Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Trial participating centre

Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Trial participating centre

Royal Bolton Hospital
Minerva Road
Bolton
BL4 0JR
United Kingdom

Trial participating centre

Salford Royal Hospital
Stott Lane
Salford
M6 8HD
United Kingdom

Trial participating centre

University Hospital Coventry
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Trial participating centre

New Cross Hospital
Wolverhampton Road
Wolverhampton
WV10 0QP
United Kingdom

Trial participating centre

Macclesfield District General Hospital
Victoria Road
Macclesfield
SK10 3BL
United Kingdom

Trial participating centre

Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom

Trial participating centre

Blackpool Victoria Hospital
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom

Trial participating centre

Ipswich Hospital
Turner Road
Ipswich
CO4 5JL
United Kingdom

Trial participating centre

Queen's Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

Dorset County Hospital
Williams Avenue
Dorchester
DT1 2JY
United Kingdom

Trial participating centre

Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom

Trial participating centre

Royal Blackburn Teaching Hospital
Casterton Avenue
Blackburn
BB10 2PQ
United Kingdom

Trial participating centre

Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom

Trial participating centre

Warwick Hospital
Lakin Road
Warwick
CV34 5BW
United Kingdom

Trial participating centre

Peterborough City Hospital
Bretton Gate
Peterborough
PE3 9GZ
United Kingdom

Trial participating centre

Aberdeen Royal Infirmary
Foresterhill Road
Aberdeen
Foresterhill Road
United Kingdom

Trial participating centre

Royal Alexandra Hospital
Corsebar Road
Paisley
PA2 9PN
United Kingdom

Trial participating centre

John Hunter Hospital
Lookout Road New Lambton Heights
Newcastle
NSW 2305
Australia

Sponsor information

Organisation

University of Birmingham

Sponsor details

Dr Birgit Whitman
Head of Research Governance and Integrity
Research Support
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 7618
researchgovernance@contacts.bham.ac.uk

Sponsor type

University/education

Website

Organisation

University of Newcastle Australia

Sponsor details

University Drive
Callaghan
Newcastle
NSW 2308
Australia
-
researchintegrity@newcastle.edu.au

Sponsor type

University/education

Website

http://www.newcastle.edu.au/

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF); Grant Codes: PB-PG-0416-20045

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Health and Medical Research Council

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
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.

Intention to publish date

31/07/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.