Surgical Wounds Healing By Secondary Intention - 2
| ISRCTN | ISRCTN26277546 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26277546 |
| Secondary identifying numbers | Sponsor ID: R2319; HTA 17/42/94; 40908 |
- Submission date
- 15/02/2019
- Registration date
- 25/03/2019
- Last edited
- 03/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
After an operation, most wounds are closed using stitches or staples. Some wounds cannot be closed in this way and are left open. Sometimes wounds that have been closed may open up again. These “open” wounds are usually left to heal, over time, from the bottom up rather than attempting to close them again by some other means (healing by secondary intention). The most common treatment for these wounds is plain dressings. Another type of treatment is Negative Pressure Wound Therapy (NPWT) which is a relatively new treatment for open surgical wounds. It uses a small machine to apply suction to a wound through a special dressing. Use of NPWT has become more common and is used in around one third of people with open surgical wounds. It is not known which of these (NPWT or wound dressings) is the most effective treatment for surgical wounds healing by secondary intention and which treatment is best value for money. The aim of this study is to compare NPWT to normal wound dressings to see if it makes any difference to how quickly these open wounds heal.
Who can participate?
Patients aged 16 or older with a surgical wound healing by secondary intention
What does the study involve?
Participants receive one of the two treatments (NPWT or wound dressings), selected at random using a computer system. The two groups are compared over 12 months including how long it takes their wounds to heal, number of infections, hospital admissions and further operations, and how much both treatments cost.
What are the possible benefits and risks of participating?
The information from this study may help to treat people with open wounds more effectively in the future. As with any treatment there are always potential risks, although side effects in both treatments are very uncommon. Where negative pressure wound therapy machines are used, the device may present a trip hazard and so care should be taken when moving around. Where a wound is located on the stomach, there is an increased risk of developing a fistula, an abnormal opening between organs and the skin. Where normal wound dressings are used, there may be a need for frequent dressing changes, sometimes daily. These are usually completed by a nurse. Being in this study will not harm or disadvantage participant's care in any way and participants will be monitored regularly as part of usual NHS care.
Where is the study run from?
University of York (UK)
When is the study starting and how long is it expected to run for?
November 2018 to January 2024
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Catherine Arundel
catherine.arundel@york.ac.uk
Contact information
Scientific
York Trials Unit
Lower Ground Floor
ARRC Building
Department of Health Science
University of York
Heslington
York
YO10 5DD
United Kingdom
 ORCID ID |
0000-0003-0512-4339 |
|---|---|
| Phone | +44 (0)1904 321 116 |
| catherine.arundel@york.ac.uk |
Public
York Trials Unit
Lower Ground Floor
ARRC Building
Department of Health Science
University of York
Heslington
York
YO10 5DD
United Kingdom
| ORCID ID |
0000-0003-0512-4339 |
|---|---|
| Phone | +44 (0)1904 321 116 |
| catherine.arundel@york.ac.uk |
Study information
| Study design | Pragmatic multi-centre randomized controlled trial |
|---|---|
| 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 | A pragmatic, multicentre, randomised controlled trial to assess the clinical and cost effectiveness of negative pressure wound therapy versus usual care for surgical wounds healing by secondary intention (SWHSI 2) |
| Study acronym | SWHSI-2 |
| Study objectives | Negative Pressure Wound Therapy (NPWT) is superior to usual care in the treatment of surgical wounds healing by secondary intention (SWHSI). |
| Ethics approval(s) | Approved 05/04/2019, Yorkshire and The Humber - Leeds East Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ; +44(0)207 1048 088; nrescommittee.yorkandhumber-leedseast@nhs.net), ref: 19/YH/0054 |
| Health condition(s) or problem(s) studied | Surgical wounds healing by secondary intention |
| Intervention | Current intervention as of 01/04/2022: Patients with a potential planned SWHSI (pre-operatively) or a SWHSI occurring at any point following surgery will be screened for potential eligibility by their clinical care team or GP. Patients who agree to take part will receive one of the two treatments selected at random using a computer system. Intervention: Negative Pressure Wound Therapy (NPWT). Participants will be treated with negative pressure wound therapy (NPWT). The patients wound is filled with a suitable dressing, and a liner may also be used to protect the wound. A vacuum pump is then attached which applies suction to the wound. A disposable, plastic canister slots into the pump to collect wound exudate and this is removed and replaced either when it becomes full, or at least once a week. The device is generally used as part of the SWHSI treatment pathway rather than to the point of healing and is administered by both nurses and clinicians. The use of any CE marked NPWT device, providing pressure of 60-150mmHg, in use within the NHS will be permitted in this trial, given that the principles of any device are similar and there is no evidence to suggest clinical or cost-effectiveness differences between devices. The device will be used in accordance with manufacturer guidance, and the clinical care team, in conjunction with local treatment guidelines, will determine the duration of device use, and whether this includes continuous or intermittent pressure cycles. Control: Usual Care (no NPWT) Usual care will be that used locally, without NPWT. This is most likely to be other sorts of wound dressings and use of any dressing type will be permitted. The frequency of dressing changes will continue as per standard practice. Participants in both groups will be followed up by telephone on a weekly basis until the participant's wound has healed. Following wound healing, a face to face visit will be completed to assess the wound, complete a wound infection assessment, and to collect a photograph of the healed wound. Healing status will then be confirmed by telephone for two further weeks. Participants in both groups will be asked to complete short questionnaires at 3 months, 6 months and 12 months which include assessment of pain, wound infection, quality of life and resource use. Previous intervention: Patients with a potential planned SWHSI (pre-operatively) or a SWHSI occurring at any point following surgery will be screened for potential eligibility by their clinical care team or GP. Patients who agree to take part will receive one of the two treatments selected at random using a computer system. Intervention: Negative Pressure Wound Therapy (NPWT). Participants will be treated with negative pressure wound therapy (NPWT). The patients wound is filled with a suitable dressing, and a liner may also be used to protect the wound. A vacuum pump is then attached which applies suction to the wound. A disposable, plastic canister slots into the pump to collect wound exudate and this is removed and replaced either when it becomes full, or at least once a week. The device is generally used as part of the SWHSI treatment pathway rather than to the point of healing and is administered by both nurses and clinicians. The use of any CE marked NPWT device, providing pressure of 60-150mmHg, in use within the NHS will be permitted in this trial, given that the principles of any device are similar and there is no evidence to suggest clinical or cost-effectiveness differences between devices. The device will be used in accordance with manufacturer guidance, and the clinical care team, in conjunction with local treatment guidelines, will determine the duration of device use, and whether this includes continuous or intermittent pressure cycles. Control: Usual Care (no NPWT) Usual care will be that used locally, without NPWT. This is most likely to be other sorts of wound dressings and use of any dressing type will be permitted. The frequency of dressing changes will continue as per standard practice. Participants in both groups will be followed up by telephone on a weekly basis until the participant's wound has healed. Following wound healing, three face to face visits will be completed to assess the wound, complete a wound infection assessment, and to collect photographs of the healed wound. Participants in both groups will be asked to complete short questionnaires at 3 months, 6 months and 12 months which include assessment of pain, wound infection, quality of life and resource use. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Negative Pressure Wound Therapy; Usual wound dressings |
| Primary outcome measure | Current primary outcome measure as of 18/11/2020: Time to healing in days from randomisation (defined using the commonly used and clinically certified criteria ‘complete epithelial cover in the absence of a scab (eschar)’). Confirmation of wound healing by a health care professional will initially be participant-reported through weekly telephone contact with the research nurse. Participants will be asked to report if their clinician or nurse has indicated that their wound is healed. In the event the participant reports their wound to be healed, but this has not been confirmed by a healthcare professional, the research nurse will contact the clinical care team to obtain this confirmation. Once wound healing has been confirmed by a healthcare professional and treatment has ceased, participants will undergo clinical assessments on three subsequent consecutive weeks. The first healing visit will be completed face to face wherever possible, during which standardised photographs will be taken of the wound for blinded outcome verification. We will also ask participants to take and return a photograph of the wound themselves. Study-specific instructions will be provided to the participant. The second and third post healing visits may be completed by telephone if required. _____ Previous primary outcome measure: Time to healing in days from randomisation (defined using the commonly used and clinically certified criteria ‘complete epithelial cover in the absence of a scab (eschar)’). Confirmation of wound healing by a health care professional will initially be participant-reported through weekly telephone contact with the research nurse. Participants will be asked to report if their clinician or nurse has indicated that their wound is healed. In the event the participant reports their wound to be healed, but this has not been confirmed by a healthcare professional, the research nurse will contact the clinical care team to obtain this confirmation. Once wound healing has been confirmed by a healthcare professional and treatment has ceased, participants will undergo clinical assessments on three subsequent consecutive weeks during which standardised photographs will be taken of the wound for blinded outcome verification. |
| Secondary outcome measures | Current Secondary outcome measures as of 11/03/2024: 1. Clinical events including antibiotic treatment, hospital admission or discharge, treatment status (including reasons for dressing or treatment failure or change), re-operation (including skin grafting and closure surgery*), amputation and death will be assessed using clinic records and patient-reported events on a weekly basis until the point of wound healing. *The decision for closure surgery will be made blinded to treatment allocation as far as is possible 2. Wound infection assessed using the Bluebelle Wound Healing Questionnaire (WHQ). The questionnaire includes items to assess signs, symptoms and wound care interventions indicative of surgical site infection (SSI) and can be completed by patient self-report or by healthcare professionals. The tool may be used to assess wounds in hospital or after the patient has been discharged. The WHQ will be completed by the participants themselves at baseline, 3 month follow-up assessments, and will also be completed by the patient at the initial healing visit 3. Wound pain, assessed using a visual analogue scale (with anchors 0 ‘no pain’ and 10 ‘worst imaginable pain’). The scale will be completed by the participants themselves at baseline, 3, 6 and 12 month follow-up assessments 4. Quality of life, measured using the EQ-5D-5L at baseline, 3 months, 6 months and 12 months follow-up assessments 5. Resource use: wound-related NHS consultations, support (e.g. occupational therapy, in-home adaptions) and out-of-pocket costs collected using a patient-reported questionnaire at baseline, 3, 6 and 12 months Previous secondary outcome measures as of 01/04/2022: 1. Clinical events including antibiotic treatment, hospital admission or discharge, treatment status (including reasons for dressing or treatment failure or change), re-operation (including skin grafting and closure surgery*), amputation and death will be assessed using clinic records and patient-reported events on a weekly basis until the point of wound healing. * The decision for closure surgery will be made blinded to treatment allocation as far as is possible 2. Wound infection assessed using the Bluebelle Wound Healing Questionnaire (WHQ). The questionnaire includes items to assess signs, symptoms and wound care interventions indicative of surgical site infection (SSI) and can be completed by patient self-report or by healthcare professionals. The tool may be used to assess wounds in hospital or after the patient has been discharged. The WHQ will be completed by the participants themselves at baseline, 3, 6 and 12 month follow up assessments, and will also be completed by the patient at the initial healing visit 3. Wound pain, assessed using a visual analogue scale (with anchors 0 ‘no pain’ and 10 ‘worst imaginable pain’). The scale will be completed by the participant themselves at baseline, 3, 6 and 12 month follow up assessments 4. Quality of life, measured using the EQ-5D-5L at baseline, 3 months, 6 months and 12 months follow up assessments 5. Resource use: wound-related NHS consultations, support (e.g. occupational therapy, in home adaptions) and out of pocket costs collected using a patient-reported questionnaire at baseline, 3, 6 and 12 months Previous secondary outcome measures: 1. Clinical events including antibiotic treatment, hospital admission or discharge, treatment status (including reasons for dressing or treatment failure or change), re-operation (including skin grafting and closure surgery*), amputation and death will be assessed using clinic records and patient-reported events on a weekly basis until the point of wound healing. * The decision for closure surgery will be made blinded to treatment allocation 2. Wound infection assessed using the Bluebelle Wound Healing Questionnaire (WHQ). The questionnaire includes items to assess signs, symptoms and wound care interventions indicative of surgical site infection (SSI) and can be completed by patient self-report or by healthcare professionals. The tool may be used to assess wounds in hospital or after the patient has been discharged. The WHQ will be completed by the participants themselves at baseline, 3, 6 and 12 month follow up assessments, and will also be completed by the patient at the initial healing visit 3. Wound pain, assessed using a visual analogue scale (with anchors 0 ‘no pain’ and 10 ‘worst imaginable pain’). The scale will be completed by the participant themselves at baseline, 3, 6 and 12 month follow up assessments 4. Quality of life, measured using the EQ-5D-5L at baseline, 3 months, 6 months and 12 months follow up assessments 5. Resource use: wound-related NHS consultations, support (e.g. occupational therapy, in home adaptions) and out of pocket costs collected using a patient-reported questionnaire at baseline, 3, 6 and 12 months |
| Overall study start date | 01/11/2018 |
| Completion date | 31/01/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 696 |
| Total final enrolment | 686 |
| Key inclusion criteria | 1. Aged 16 years or over 2. Has an acute SWHSI (i.e. a wound left open as planned following surgery or a wound initially closed using sutures, clips, or other closure methods and dehisced along the whole or part of its length, and of less than 6 weeks in duration), arising from any surgical specialty and occurring on any part of the body, deemed appropriate to receive either NPWT or wound dressing treatment 3. Has a SWHSI that is considered ready for NPWT treatment (i.e. contains at least 80% viable tissue or has only a very thin layer of slough requiring no further debridement) 4. Patient is not deemed to be malnourished, as per NICE guidelines CG 32 (BMI <18.5 kg/m2; unplanned* weight loss >10% in the last 3-6 months; BMI <20kg/m2 and unplanned* weight loss >5% in the last 3-6 months) or assessed as at high risk of malnutrition using the Malnutrition Universal Screening Tool (MUST) *Patients with weight loss arising either from underlying comorbidity (e.g. ulcerative colitis) or from the reasons for surgery being completed (e.g. bowel cancer) may be included at the clinician’s discretion 5. Willing and able to give informed consent and provide follow-up data |
| Key exclusion criteria | Current participant exclusion criteria as of 01/04/2022: 1. Life expectancy of less than 6 months e.g. undergoing end stage palliative care 2. Active systemic infection (including osteomyelitis) at baseline as defined by clinical and/or laboratory assessment. Note: Patients who have an active infection, but are improving following 1 week’s duration of antibiotics may be included at the clinician’s discretion 3. Inadequate haemostasis or patients who are at risk of bleeding 4. Chronic wounds non-surgical in origin (e.g. pressure ulcers or foot ulcers)* *Note diabetic foot ulcers which have been incised and drained or debrided as an inpatient in theatre may be included given this constitutes a surgical wound. 5. Current wound has previously been, or is currently being, treated with NPWT 6. Planned delayed primary closure of the wound 7. Contraindication to NPWT including: presence of unclear undermining in the wound cavity; presence of necrotic tissue, malignant tissue or eschar; wounds involving exposed blood vessels and/or organs, anastomotic sites and/or nerves (including the “open abdomen” where the abdominal fascia is open); wounds situated where, in the opinion of the treating clinician, a vacuum seal cannot be obtained; presence of a non-enteric or unexplored fistula; people requiring emergency airway aspiration, pleural mediastinal or chest tube drainage or surgical suction (removed 07/11/2019: people with a sensitivity or allergy to silver) 8. Currently participating in another wound research study, where the primary outcome time point has not yet been reached Previous participant exclusion criteria: 1. Life expectancy of less than 6 months e.g. undergoing end stage palliative care 2. Active systemic infection (including osteomyelitis) at baseline as defined by clinical and/or laboratory assessment. Note: Patients who have an active infection, but are improving following 1 week’s duration of antibiotics may be included at the clinician’s discretion 3. Inadequate haemostasis or patients who are at risk of bleeding 4. Chronic wounds non-surgical in origin (e.g. pressure ulcers or foot ulcers) 5. Current wound has previously been, or is currently being, treated with NPWT 6. Planned delayed primary closure of the wound 7. Contraindication to NPWT including: presence of unclear undermining in the wound cavity; presence of necrotic tissue, malignant tissue or eschar; wounds involving exposed blood vessels and/or organs, anastomotic sites and/or nerves (including the “open abdomen” where the abdominal fascia is open); wounds situated where, in the opinion of the treating clinician, a vacuum seal cannot be obtained; presence of a non-enteric or unexplored fistula; people requiring emergency airway aspiration, pleural mediastinal or chest tube drainage or surgical suction (removed 07/11/2019: people with a sensitivity or allergy to silver) 8. Currently participating in another wound research study, where the primary outcome time point has not yet been reached |
| Date of first enrolment | 01/05/2019 |
| Date of final enrolment | 13/01/2023 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Anlaby Road
Hull
HU3 2JZ
United Kingdom
Edgbaston
Birmingham
B15 2TH
United Kingdom
Prescot Street
Liverpool
L7 8XP
United Kingdom
Armthorpe Road
Doncaster
DN2 5LT
United Kingdom
Pensnett Road
Dudley
DY1 2HQ
United Kingdom
Treliske
Truro
TR1 3LJ
United Kingdom
Praed Street
London
W2 1NY
United Kingdom
High Heaton
Newcastle
NE7 7DN
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
Norwich
NR3 7UY
United Kingdom
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
Tooting
London
SW17 0QT
United Kingdom
Aberford Road
Wakefield
WF1 4DG
United Kingdom
Rochdale Road
Oldham
OL1 2JH
United Kingdom
Cardiff Road
Newport
NP20 2UB
United Kingdom
Kings Lynn
PE30 4ET
United Kingdom
Nursery Park
Ashington
NE63 0HP
United Kingdom
Derby
DE22 3NE
United Kingdom
Kayll Road
Sunderland
SR4 7TP
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Portsmouth Road
Frimley
Camberley
GU16 7UJ
United Kingdom
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
Eaglesham Road
Glasgow
G75 5RG
United Kingdom
51 Little France Crescent
Old Dalkeith Road
Edinburgh
EH16 4SA
United Kingdom
Bristol
BS10 5NB
United Kingdom
Pond Street
London
NW3 2QG
United Kingdom
Groby Road
Leicester
LE3 9QP
United Kingdom
Shrewsbury
SY3 8XQ
United Kingdom
Charles Hastings Way
Worcester
WR5 1DD
United Kingdom
Sponsor information
Hospital/treatment centre
R&D Department, 2nd Floor Daisy Building
Castle Hill Hospital
Cottingham
Hull
HU16 5JQ
England
United Kingdom
| Phone | +44 (0)1482 461883 |
|---|---|
| research.development@hey.nhs.uk | |
| Website | https://www.hey.nhs.uk/research/contact-research/ |
"ROR" |
https://ror.org/01b11x021 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Documentation relating to the study will be made available as the study progresses. Results will be published in peer reviewed journals. Summaries of the findings will be sent to NICE and other relevant bodies so that findings can inform clinical practice. The trialists will also work with the relevant National Clinical Director in the Department of Health to ensure findings are considered when implementing policy. The trialists will also work with relevant Speciality Advisory Committees to incorporate findings into training curriculum's for clinicians. |
| IPD sharing plan | Anonymised datasets generated and analysed during the current study will be stored in a publicly available open research repository (https://osf.io/echxv). Data is anticipated to be available via this repository by end 2024, following completion of analysis and subsequent publication. Sharing of this anonymised data is covered by original participant consent for the SWHSI-2 trial which permits sharing of data to support future research via sharing anonymously. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 25/10/2021 | 19/01/2023 | Yes | No | |
| Other files | Health economics analysis plan version 1.0 |
14/12/2022 | 03/02/2023 | No | No |
| Statistical Analysis Plan | version 1.0 | 14/12/2022 | 03/02/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 15/04/2025 | 23/04/2025 | Yes | No | |
| Dataset | 13/05/2025 | 21/05/2025 | No | No | |
| Results article | outcomes and learning from the internal pilot phase and main trial | 02/07/2025 | 03/07/2025 | Yes | No |
Additional files
- ISRCTN26277546_SAP_V1.0_14Dec22.pdf
- ISRCTN26277546_HealthEconomicsAnalysisPlan_V1.0_14Dec22.pdf
- Health economics analysis plan
Editorial Notes
03/07/2025: Publication reference added.
21/05/2025: Dataset added.
23/04/2025: Publication reference added.
12/03/2024: The overall end date was changed from 31/12/2023 to 31/01/2024.
11/03/2024: The following changes were made to the study record:
1. The secondary outcome measures were updated.
2. Study website updated.
3. The Shrewsbury and Telford Hospital NHS Trust and Worcestershire Acute Hospitals NHS Trust were added to the study participating centres.
11/12/2023: A contact confirmed that the study dates were correct.
30/08/2023: The following changes were made to the trial record:
1. The device name was added.
2. The participant level data sharing statement was added.
03/02/2023: Statistical analysis plan and health economic analysis plan uploaded.
19/01/2023: Publication reference added.
17/01/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2022 to 13/01/2023.
2. The overall end date was changed from 31/03/2023 to 31/12/2023.
3. The plain English summary was updated to reflect these changes.
4. The total final enrolment was added.
01/04/2022: The following changes have been made:
1. The recruitment end date has been changed from 30/09/2021 to 31/12/2022.
2. The overall trial end date has been changed from 30/04/2022 to 31/03/2023 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 31/10/2022 to 30/06/2024.
4. The intervention has been updated.
5. The secondary outcome measures have been updated.
6. The participant exclusion criteria have been updated.
7. The trial participating centres “Manchester University NHS Foundation Trust”, “Frimley Health NHS Foundation Trust”, "Bradford Teaching Hospitals NHS Foundation Trust", "NHS Lanarkshire", "NHS Lothian", "North Bristol NHS Trust", "Royal Free London NHS Foundation Trust", and “University Hospitals of Leicester NHS Trust” have been added.
17/05/2021: The recruitment end date has been changed from 30/04/2021 to 30/09/2021.
18/11/2020: The following changes were made to the trial record:
1. The primary outcome measure was changed.
2. The trial participating centres University Hospitals of Derby and Burton and Sunderland Royal Hospital were added.
23/07/2020: The following changes were made to the trial record:
1. Recruitment to this study is no longer paused.
2. The trial participating centres were updated to remove Manchester University NHS Foundation Trust
and add University Hospitals of Birmingham NHS Foundation Trust, St Georges University Hospitals NHS Foundation Trust, Mid Yorkshire Hospitals NHS Trust, Pennine Acute Hospitals NHS Trust, Aneurin Bevan University Health Board, Queen Elizabeth Hospital Kings Lynn NHS Trust and Northumbria Healthcare NHS Foundation Trust.
16/04/2020: Due to current public health guidance, recruitment for this study has been paused.
07/11/2019: The exclusion criteria were updated.
24/07/2019: The ethics approval was added.
25/03/2019: Trial's existence confirmed by the NIHR.
