About this trial
MARLIN is a stratified, multi-arm, multi-stage factorial randomised platform trial aiming to reduce the incidence of post-operative surgical site infection (SSI).
Eligibility criteria
Qualifiers
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
Disqualifiers
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.)
Patient unable to complete post-operative follow-up (i.e., will not be contactable after discharge).
Patients undergoing clean surgical procedures.
Trial design
Treatments tested in this trial
- Chlorhexidine Gluconate 2.0% to 4.0% (e.g. Hibiscrub) preoperative shower
- Intraoperative wound wash (e.g. Granudacyn)
- DACC surgical wound dressing (e.g. Leukomed Sorbact)
Treatment groups
6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
University of Birmingham
Lead sponsor
Kigali University Teaching Hospital
Collaborator
Université d'Abomey-Calavi
Collaborator