A Stratified, Multi-ARm, muLti-site Randomised Platform Trial Aiming to Reduce the INcidence of Post-operative SSI

Launched by UNIVERSITY OF BIRMINGHAM · Jun 18, 2024

Keywords

ClinConnect Summary

The MARLIN trial is a research study designed to find ways to reduce the risk of surgical site infections (SSIs) after abdominal surgeries. SSIs are infections that can occur at the site of a surgical incision, and this trial aims to explore various methods to minimize these risks. It is not yet recruiting participants, but once it starts, it will involve patients of all ages, starting from 5 years old, who are scheduled for either emergency or planned abdominal surgery.

To be eligible for the trial, participants need to have an abdominal incision that is at least 5 centimeters long and will be undergoing a surgery that could potentially lead to infection. Those who are unable to be reached for follow-up after surgery, or who are having procedures that are considered "clean" (meaning there is a low risk of infection), will not be able to join the study. If you or a family member are considering participation, you can expect to provide consent before the surgery and will be monitored for any signs of infection after the procedure. This research is important as it aims to improve patient safety and outcomes following surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with at least one abdominal incision that is ≥5cm (open or laparoscopic extraction site), with an anticipated clean-contaminated, contaminated, or dirty surgical wound. Definitions and examples of contamination are given in Table 1.
• • Patients undergoing emergency (surgery on an unplanned admission) or elective (surgery on a planned admission) operations.
• • Any operative indication for abdominal surgery (excluding caesarean section; see exclusion criteria).
• • Patient able and willing to provide written informed consent (signature or a fingerprint) prior to surgery (including emergency cases).
• • Patients aged 5 years and over. (This criteria MUST be made country-specific. Each country will decide the lower (and upper, if applicable according to local regulations age limit for the trial. This will be dependent on country-specific regulatory approvals. Age eligibility will vary by country.)
• Exclusion Criteria:
• • Patient unable to complete post-operative follow-up (i.e., will not be contactable after discharge).
• • Patients undergoing clean surgical procedures.
• • Patients undergoing an obstetrics procedure, including caesarean sections.