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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5+
SponsorUniversity of Birmingham

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

10,092 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

University of Birmingham

Lead sponsor

Kigali University Teaching Hospital

Collaborator

Université d'Abomey-Calavi

Collaborator