Health Trials

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

ConditionSurgical Site Infection
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Chlorhexidine Gluconate 2.0% to 4.0% (e.g. Hibiscrub) preoperative shower

    Other intervention

    Chlorhexidine Gluconate 2.0% to 4.0% (e.g. Hibiscrub) preoperative shower

  • Intraoperative wound wash (e.g. Granudacyn)

    Other intervention

    Intraoperative wound wash (e.g. Granudacyn)

  • DACC surgical wound dressing (e.g. Leukomed Sorbact)

    Other intervention

    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.

Group A: Intervention: Chlorhexidine Gluconate 2.0% to 4.0% (e.g. Hibiscrub) preoperative showerExperimental treatment 1 intervention
Group B: Comparator: Standard preoperative preparationActive comparator 1 intervention
Group C: Intervention: Intraoperative wound wash (e.g. Granudacyn)Experimental treatment 1 intervention
Group D: Comparator: Standard intraoperative preparationActive comparator 1 intervention
Group E: Intervention: DACC surgical wound dressing (e.g. Leukomed Sorbact)Experimental treatment 1 intervention
Group F: Comparator: Standard post-operative wound careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Surgical site infection

The primary outcome is surgical site infection (SSI) within 30 days post-surgery, defined according to Centre for Disease Control criteria collected using an adapted, validated Wound Healing questionnaire (TALON).

Time frame
Within 30 days of surgery

Secondary outcomes

1

Surgical site infection

SSI at or prior to discharge from hospital

Time frame
At or prior to discharge from hospital, usually within approximately 7 days of surgery
2

Mortality

Mortality (and likely cause)

Time frame
Within 30-days post-surgery
3

Length of hospital stay

Length of hospital stay for index admission

Time frame
Within 30 days of surgery
4

Return to normal activities

Return to normal activities (e.g. work, school, or family duties)

Time frame
Within 30 days of surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Birmingham

Lead sponsor

Kigali University Teaching Hospital

Collaborator

Université d'Abomey-Calavi

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: