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
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	334321
Protocol serial number	RG_24-006
Sponsor	University of Birmingham
Funder	European Society of Coloproctology

Submission date: 14/05/2025
Registration date: 20/05/2025
Last edited: 19/05/2025

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Prof Thomas Pinkney
Scientific, Principal investigator

Institute of Translational Medicine
Mindelsohn Way
Birmingham
B15 2TH
United Kingdom

ORCID ID	0000-0001-7320-6673
Email	T.pinkney@bham.ac.uk

Mr James Keatley
Public

Institute of Translational Medicine
Mindelsohn Way
Birmingham
B15 2TH
United Kingdom

Phone	07305907886
Email	j.keatley@bham.ac.uk

Study information

Primary study design	Observational
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
Secondary study design	Cohort study
Study type	Participant information sheet
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(s)	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
Key secondary outcome measure(s)	Clinician-derived surgical outcomes data for up to 30 days post-operation
Completion date	31/10/2026

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	99 Years
Sex	All
Target sample size at registration	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

United Kingdom
England
Belgium
Denmark
Germany
Greece
India
Ireland
Italy
Netherlands
Spain
Sri Lanka

Study participating centre

Wirral University Teaching Hospital NHS Foundation Trust

Arrowe Park Hospital
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version 1.0	30/01/2024	19/05/2025	No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Additional files

47337 WOLVERINE Study Protocol COHORT - v1.0 30th Jan 2024.pdf: Protocol file

Editorial Notes

19/05/2025: Trial's existence confirmed by West Midlands - South Birmingham Research Ethics Committee.