An international cohort study of wound closure and surgical site infection prevention strategies in abdominal surgery
| ISRCTN | ISRCTN55324472 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55324472 |
| IRAS number | 334321 |
| Secondary identifying numbers | RG_24-006 |
- Submission date
- 14/05/2025
- Registration date
- 20/05/2025
- Last edited
- 19/05/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
WOLVERINE stands for Wound Closure and Surgical Site Infection Prevention Strategies in Abdominal Surgery. The overall aim is to assess the different practices of wound closure techniques and surgical site prevention strategies around the world. The study will also look at the effect of wound closure and surgical site infection prevention practices on the rate of abdominal wound failure from 30 days to 1 year after surgery. The data collected will be used to help design a future interventional trial on wound closure and surgical site infection prevention. WOLVERINE was developed by the European Society of Coloproctology (ESCP).
Who can participate?
Patients aged 18 or over, undergoing abdominal surgery.
What does the study involve?
Participants agreeing to take part in the study will be asked to complete questionnaires about how they are feeling after their surgery. These questionnaires will be collected at 30 days after surgery, at 60 days, 90 days, 6 months and at 1 year. Participation will be for 12 months.
What are the possible benefits and risks of participating?
No benefits given at registration.
The research team do not expect there to be any disadvantages or risks to taking part in the WOLVERINE cohort study. However, they know that taking part takes time and completion of the questionnaires may sometimes be inconvenient.
Where is the study run from?
The cohort study is being coordinated by the ESCP team based at the University of Birmingham, UK, and the University of Birmingham is the Sponsor. A company, Ethicon, is supporting ESCP in developing educational material to help surgeons prevent surgical wound problems.
When is the study starting and how long is it expected to run for?
January 2024 to October 2026
Who is funding the study?
ESCP
Who is the main contact?
wolverine@contacts.bham.ac.uk
Contact information
Scientific, Principal Investigator
Institute of Translational Medicine
Mindelsohn Way
Birmingham
B15 2TH
United Kingdom
 ORCID ID |
0000-0001-7320-6673 |
|---|---|
| T.pinkney@bham.ac.uk |
Public
Institute of Translational Medicine
Mindelsohn Way
Birmingham
B15 2TH
United Kingdom
| Phone | 07305907886 |
|---|---|
| j.keatley@bham.ac.uk |
Study information
| Study design | International prospective cohort study collecting short-term clinical outcomes up to 30 days and long-term patient-reported outcomes up to 1 year |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format |
| Scientific title | An international cohort study of Wound Closure and Surgical Site Infection Prevention Strategies in Abdominal Surgery |
| Study acronym | WOLVERINE |
| Study objectives | WOLVERINE is an observational study. This cohort study will be the first large-scale international study to investigate the impact of wound closure and early wound complications on long-term outcomes. |
| Ethics approval(s) |
Approved 28/05/2024, Proportionate Review Sub-committee of the West Midlands - South Birmingham Research Ethics Committee (2 Redman Place, London, E20 1QJ, United Kingdom; -; southbirmingham.rec@hra.nhs.uk), ref: 24/WM.0115 |
| Health condition(s) or problem(s) studied | Adult patients (age 18 years and above) undergoing general or colorectal surgical procedures using any type of abdominal incision measuring at least 5 cm (including extraction sites) |
| Intervention | Patients will receive quality of life questionnaires at 30-days, 60-days, 90-days, 6-months and 1-year after the date of surgery. |
| Intervention type | Other |
| Primary outcome measure | 1. Patient, disease, and operation-related factors are measured using patient medical notes at baseline (time of surgery) 2. Wound closure techniques are measured using patient medical notes at baseline (time of surgery) 3. Surgical site infection (SSI) prevention measures are measured using patient medical notes at baseline (time of surgery) 4. Wound healing is measured using the Bluebelle Wound Healing Questionnaire at 30, 60, and 90 days, and 6 and 12 months post-operation 5. Post-operative recovery and return to normal activities are measured using the Patient-Reported Wound Recovery PROM at 30, 60, and 90 days, and 6 and 12 months post-operation 6. Hospital re-admissions are measured using patient medical records at 30, 60, and 90 days, and 6 and 12 months post-operation 7. Re-operations are measured using patient medical records at 30, 60, and 90 days, and 6 and 12 months post-operation 8. Incisional hernia occurrence is measured using the ESCP Incisional Hernia PROM at 12 months post-operation 9. Patient quality of life is measured using the EQ-5D at 30, 60, and 90 days, and 6 and 12 months post-operation 10. Patient quality of life related to wound healing is measured using the Bluebelle Wound Healing Questionnaire at 30, 60, and 90 days, and 6 and 12 months post-operation 11. Patient quality of life related to wound recovery is measured using the Patient-Reported Wound Recovery PROM at 30, 60, and 90 days, and 6 and 12 months post-operation 12. Patient quality of life related to hernia symptoms is measured using the HerQles Questionnaire at 6 and 12 months post-operation 13. Patient-reported incisional hernia occurrence is measured using the ESCP Incisional Hernia PROM at 12 months post-operation 14. Comparison of quality of life for patients with and without wound healing issues and/or incisional hernia is measured using EQ-5D, Bluebelle Wound Healing Questionnaire, Patient-Reported Wound Recovery PROM, HerQles Questionnaire, and ESCP Incisional Hernia PROM at 30, 60, and 90 days, and 6 and 12 months post-operation |
| Secondary outcome measures | Clinician-derived surgical outcomes data for up to 30 days post-operation |
| Overall study start date | 01/01/2024 |
| Completion date | 31/10/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | Both |
| Target number of participants | 1000 |
| Key inclusion criteria | 1. Adult patients (age 18 years and above) undergoing general or colorectal surgical procedures 2. Elective (planned admission), expedited (within two weeks), or emergency (unplanned admission) surgery 3. General and colorectal procedures using any type of abdominal incision measuring at least 5 cm (including extraction sites) 4. Able to give written informed consent |
| Key exclusion criteria | 1. Patients undergoing incisional, ventral, umbilical, and inguinal/femoral hernia repair 2. Simultaneous hyperthermic intraperitoneal chemotherapy (HIPEC) and/or cytoreductive surgery 3. Stoma reversal without additional laparotomy incision 4. Anyone who does not have an email address or who does not have access to the internet or a smart device |
| Date of first enrolment | 30/05/2025 |
| Date of final enrolment | 31/10/2025 |
Locations
Countries of recruitment
- Belgium
- Denmark
- England
- Germany
- Greece
- India
- Ireland
- Italy
- Netherlands
- Spain
- Sri Lanka
- United Kingdom
Study participating centre
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom
Sponsor information
University/education
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| researchgovernance@contacts.bham.ac.uk | |
| Website | https://www.birmingham.ac.uk/ |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Research organisation
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- The European Society of COLOPROCTOLOGY, European Society of Coloprotology, ESCP
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/10/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Once WOLVERINE has finished we will publish the results in a peer reviewed medical journal . We will inform participants of the study results either via an online webinar or by the circulation of a document describing the results specifically for WOLVERINE participants. Results will also be presented at international conferences such as the European Society of Coloproctology annual conference. No individual patients will be identifiable in any publications or presentations. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.0 | 30/01/2024 | 19/05/2025 | No | No |
Additional files
Editorial Notes
19/05/2025: Trial's existence confirmed by West Midlands - South Birmingham Research Ethics Committee.
