The WOLVERINE Study

Register for WOLVERINE here

*Period 1 recruitment has now closed. The start date of the period 2 audit/cohort has been delayed awaiting U.K. ethical approval. Further information will be sent in due course*

Key dates:

• First audit recruitment window runs from 1st November 2023 – 15th December 2023 (choose your own start date from within these dates).
  • All participating centres must recruit for at least 4 weeks and include minimum 10 consecutive eligible patients.
• Second audit AND cohort study recruitment window will open on 02^nd January 2024
  • Participating sites must have started recruitment by the 01^st March 2024.

Database will be locked on the 30^th April 2024 for clinician reported outcomes.

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.

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.

• Audit Protocol: click here
• Patient information sheet: click here.
• Cohort Study Protocol: awaiting sponsor approval