An international cohort study of Wound Closure and Surgical Site Infection Prevention Strategies in Abdominal Surgery

An international cohort study of Wound Closure and Surgical Site Infection Prevention Strategies in Abdominal Surgery

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 cohort study in wound closure and SSI prevention following abdominal surgery. An international network will deliver the cohort study and collate clinical information on wound closure practices used and 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:

1. Clinical data collection: clinician-derived baseline clinical data and short-term 30-day outcomes for patients undergoing elective and/or emergency general and colorectal surgery.

2. 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.

This protocol describes the 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 85) 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:

1. Patient, disease and operation-related factors including detailed information on wound closure techniques and SSI prevention measures.
2. Clinician-derived surgical outcomes data for up to 30 days post-operation.
3. Patient-reported outcomes data at five time points: 30, 60 and 90 days, 6 and12-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.

Sample size: Based on previous studies, 1,000 patients are expected to participate in the cohort study.