2023 WOLVERINE

UK ethical approval for the cohort element of WOLVERINE has been received. The study is being set up and we aim to begin recruitment in Q2 2025. International ethical approval is currently being sought.

Launch webinar for participants

View the webinar which took place on 7 November 2023 with presentations from:

Alaa El-Hussuna - Cohort Studies: Past, Present and Future
Gabrielle van Ramshorst - WOLVERINE Audit and Cohort Study
James Keatley - How to take part
Laura Magill - Patient onboarding and data collection

and discussion afterwards.

Key dates

The first recruitment window for the audit element of the study closed in December 2023.
- Manuscript for audit outcomes is currently in draft to be submitted soon
Recruitment for the cohort element will begin in Q2 2025.

Background

The 2021 ESCP Wound Closure Survey found significant heterogeneity in common practices for abdominal wound closure and SSI prevention, including various types of fascial closure techniques and suture used, skin preparation and sterility measures taken during the surgical intervention.

Aim: To conduct a prospective, international audit and a cohort study in wound closure and SSI prevention following abdominal surgery. An international network will collate information on wound closure practices used and, within the cohort study element only, patients will provide their own short and longer-term outcomes on wound healing, recovery and return to normal function.

The data will also be used to inform the design of a future interventional trial on wound closure and SSI prevention.

Design

The study has two separate components:

Prospective audit study: clinician-derived baseline clinical data and short-term 30-day outcomes for patients undergoing elective and/or emergency general and colorectal surgery.
Cohort study: patient-reported additional outcome data for the period from 30 days to one year after surgery in the identical cohort of patients, provided that patient level informed consent is obtained.*

* All sites have the option to participate in either the audit alone or the combined audit and cohort study.

Eligibility

Centre eligibility: Any hospital or surgical unit performing elective and/or emergency general and colorectal surgery.
Patient eligibility: Adults (age 18 years and above) undergoing surgery by abdominal approach are eligible, including elective, expedited or emergency surgery by open, laparoscopic or robotic approaches with a minimum (extraction) incision length of 5 cm.

Key outcome measures

Audit study

Patient, disease and operation-related factors including detailed information on wound closure techniques and SSI prevention measures.
Clinician-derived surgical outcomes data for up to 30 days post-operation

Cohort study

Additional patient-reported outcomes data at five time points: 30, 60 90 days, 6- 12-months post-operation. Time-specific data collected on wound healing, post-operative recovery and return to normal activities, re-admissions and re-operations, development of incisional hernia at one year.