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

June 18, 2024 updated by: University of Birmingham

MARLIN: Stratified, Multi-arm, Multi-stage Factorial Randomised Platform Trial Aiming to Reduce the Incidence of Post-operative Surgical Site Infection (SSI).

MARLIN is a stratified, multi-arm, multi-stage factorial randomised platform trial aiming to reduce the incidence of post-operative surgical site infection (SSI).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

MARLIN's primary objective is assess whether different interventions used at three different time points during the participant's operative care (pre-, intra- and post-operatively) can reduce SSI at 30 days in patients undergoing abdominal surgery. MARLIN will assess the clinical effectiveness in both clean-contaminated wounds and contaminated or dirty wounds and will assess the interventions being assessed individually and in combination.

Patients (adults and children) undergoing surgery with abdominal incision of at least ≥5cm, with an anticipated clean-contaminated or contaminated or dirty wound, undergoing emergency or elective, and open or laparoscopic surgery are eligible. Participants will be recruited from hospitals within the National Institute for Health and Care Research Global Surgery Unit (NIHR GSU) network (i.e. hospitals in Benin, Rwanda, Ghana, India, Mexico, Nigeria, South Africa).

Interventions will be introduced at the preoperative window, intra-operatively and postoperatively as it is not yet known which if any of these timed intervention periods are most effective. It is planned that only one intervention will be introduced in each window. This format will allow testing for interaction between interventions including cumulated benefit. It will also enable unsuccessful interventions to be withdrawn and potentially substituted. This is a pragmatic design and wherever possible, standard care will be provided in the control arm.

After patient eligibility has been confirmed and informed consent has been obtained, patients will be randomised into the MARLIN trial by a member of the MARLIN research team at the site. Randomisation will occur within 72 hours prior to the patient's operation. Patients will be randomised dependent on which arms are available at the randomising site, and in which they consent to participate (i.e. it is possible for patients to 'opt out' of one or more of the intervention timepoints).

Patients may be randomised to receive:

  • Chlorhexidine Gluconate preoperative shower 2.0% - 4.0% (e.g. hibiscrub) or standard preoperative preparation
  • Topical wound wash before closure (e.g. granudacyn) or standard intraoperative preparation
  • Dialkylcarbamoyl chloride (DACC) wound dressing (e.g. Leukomed sorbact) or standard post-operative wound care

The randomisation ratio at each timepoint will be 1:1 between the intervention and control in the first instance, although if and when multiple intervention arms are open, the ratio may change with agreement of the data monitoring committee (DMC), with reduced randomisation into the control arm due to pooling. Eligible participants will be randomised to receive some or all of the trial interventions; sites will opt-in to each treatment depending on local deliverability, which will be reflected in the randomisation system. Randomisation will occur around the time of pre-operative assessment.

Sample size:

An internal pilot will be carried out for each intervention within the study. For each pilot, Internal pilots of 100 participants per intervention, will be undertaken to assess deliverability, safety, compliance and participant acceptability. Internal pilots will be undertaken in at least two countries for any given intervention to assess generalisability. Interventions will then be made available across the wider Global Surgery network.

For the clean-contaminated stratum, the maximum sample size required for a 3-stage design, with control SSI rate of 16%, two-sided overall alpha of 0.043, overall power of 0.86, and 20% relative reduction (3.2% absolute reduction) with 5% lost to follow up, would be 6006 participants for all 3 questions as a factorial design. As the second and third treatment will start after the first stage interim analysis of the first intervention, 7544 participants are required. 8196 participants are required if the first intervention works and leads to lower SSI rate.

For the contaminated/dirty stratum, the maximum sample size required for a 3-stage design, with control SSI rate of 30%, two-sided overall alpha of 0.043, power of 0.86 and 30% relative reduction (9% absolute reduction) with 10% lost to follow up, would require 1342 participants for all 3 questions as a factorial design. As the second and third treatment will start after first stage interim analysis of the first intervention, 1596 are required participants. 1896 participants are required if the first intervention works and leads to lower SSI rate.

Multistage analysis:

For the clean-contaminated group there will be two interim analyses, the first after 1824 participants and the second at interim analysis at 3126 for each of the questions. For the contaminated/dirty group, the first interim will happen at 372 participants, and the second at 638 participants.

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.
  • 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. ( 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 Exclusion Criteria

    • Patient unable to complete post-operative follow-up (i.e., will not be contactable after discharge).
    • Patients undergoing clean surgical procedures.

Study Type

Interventional

Enrollment (Estimated)

10092

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention: Chlorhexidine Gluconate 2.0% to 4.0% (e.g. Hibiscrub) preoperative shower

Chlorhexidine Gluconate preoperative shower (e.g. hibiscrub)

The participant may prepare themselves by undertaking whole-body disinfection with Chlorhexidine Gluconate.

On two occasions, usually the day before and the day of the operation, the participant, should wash their whole body. Research teams will remind the participant that they must complete the pre-operative washes before they arrive at theatre.

Finally the whole body should be rinsed and dried thoroughly.
Other: Chlorhexidine Gluconate 2.0% to 4.0% (e.g. Hibiscrub) preoperative shower
Chlorhexidine Gluconate 2.0% to 4.0% (e.g. Hibiscrub) preoperative shower
Active Comparator: Comparator: Standard preoperative preparation
Standard of care means whatever pre-operative cleansing is mandated according to local hospital policy.
Other: Chlorhexidine Gluconate 2.0% to 4.0% (e.g. Hibiscrub) preoperative shower
Chlorhexidine Gluconate 2.0% to 4.0% (e.g. Hibiscrub) preoperative shower
Experimental: Intervention: Intraoperative wound wash (e.g. Granudacyn)
Hypochlorous acid (HOCl) and Sodium hypochlorite (NaOCl) topical wound wash (e.g. Granudacyn)
Other: Intraoperative wound wash (e.g. Granudacyn)
Intraoperative wound wash (e.g. Granudacyn)
Active Comparator: Comparator: Standard intraoperative preparation
Standard of care means whatever irrigation of the wound site is mandated according to local hospital policy.
Other: Intraoperative wound wash (e.g. Granudacyn)
Intraoperative wound wash (e.g. Granudacyn)
Experimental: Intervention: DACC surgical wound dressing (e.g. Leukomed Sorbact)
Leukomed Sorbact (Essity), is a sterile, single-use, bacteria-binding, adhesive-bordered wound dressing. It is used to prevent SSI in closed surgical wounds that have dry to low exudate.
Other: DACC surgical wound dressing (e.g. Leukomed Sorbact)
DACC surgical wound dressing (e.g. Leukomed Sorbact)
Active Comparator: Comparator: Standard post-operative wound care
Standard of care means whatever dressing of the wound site is mandated according to local hospital policy (including no dressing). Centres mandating an active wound dressing will be excluded from the trial.
Other: DACC surgical wound dressing (e.g. Leukomed Sorbact)
DACC surgical wound dressing (e.g. Leukomed Sorbact)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical site infection
Time Frame: Within 30 days of surgery
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).
Within 30 days of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical site infection
Time Frame: At or prior to discharge from hospital, usually within approximately 7 days of surgery
SSI at or prior to discharge from hospital
At or prior to discharge from hospital, usually within approximately 7 days of surgery
Mortality
Time Frame: Within 30-days post-surgery
Mortality (and likely cause)
Within 30-days post-surgery
Length of hospital stay
Time Frame: Within 30 days of surgery
Length of hospital stay for index admission
Within 30 days of surgery
Return to normal activities
Time Frame: Within 30 days of surgery
Return to normal activities (e.g. work, school, or family duties)
Within 30 days of surgery
Unplanned wound opening
Time Frame: Within 30 days of surgery
Unplanned wound opening (i.e. not relating to necessary re-intervention)
Within 30 days of surgery
Re-operation for SSI
Time Frame: Within 30 days of surgery
Re-operation for SSI
Within 30 days of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Birmingham

Collaborators

Université d'Abomey-Calavi
Kigali University Teaching Hospital

Investigators

  • Principal Investigator: Thomas Pinkney, University of Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

May 29, 2024

First Submitted That Met QC Criteria

June 18, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Actual)

June 20, 2024

Last Update Submitted That Met QC Criteria

June 18, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG_23-086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Hospital-level data will not be released or published. Country-level analyses will only be conducted with permission of lead investigators from each participating country. Local investigators may access their data across their country to perform country-level analyses (all participating hospitals should consent to their data being used in this way).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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