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

NCT06465901 | Not Yet Recruiting DMC

• 1 other identifier: RG_23-086
• Study Type: interventional
• Target: 10,092
• Locations: 7 countries
• Sites: 7

Brief Summary

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

Conditions

Surgical Site Infection

Keywords

surgery; global surgery; SSI; surgical site infection

Outcome Measures

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).

  Within 30 days of surgery

Secondary Outcomes (6)

• Surgical site infection

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

• Mortality

  Within 30-days post-surgery

• Length of hospital stay

  Within 30 days of surgery

• Return to normal activities

  Within 30 days of surgery

• Unplanned wound opening

  Within 30 days of surgery

Study Arms (6)

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

EXPERIMENTAL

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

Comparator: Standard preoperative preparation

ACTIVE COMPARATOR

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

Intervention: Intraoperative wound wash (e.g. Granudacyn)

EXPERIMENTAL

Hypochlorous acid (HOCl) and Sodium hypochlorite (NaOCl) topical wound wash (e.g. Granudacyn)

Other: Intraoperative wound wash (e.g. Granudacyn)

Comparator: Standard intraoperative preparation

ACTIVE COMPARATOR

Standard of care means whatever irrigation of the wound site is mandated according to local hospital policy.

Other: Intraoperative wound wash (e.g. Granudacyn)

Intervention: DACC surgical wound dressing (e.g. Leukomed Sorbact)

EXPERIMENTAL

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)

Comparator: Standard post-operative wound care

ACTIVE COMPARATOR

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)

Interventions

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

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

Comparator: Standard preoperative preparation; Intervention: Chlorhexidine Gluconate 2.0% to 4.0% (e.g. Hibiscrub) preoperative shower

Intraoperative wound wash (e.g. Granudacyn) OTHER

Intraoperative wound wash (e.g. Granudacyn)

Comparator: Standard intraoperative preparation; Intervention: Intraoperative wound wash (e.g. Granudacyn)

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

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

Comparator: Standard post-operative wound care; Intervention: DACC surgical wound dressing (e.g. Leukomed Sorbact)

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients undergoing an obstetrics procedure, including caesarean sections.

Sponsors & Collaborators

• University of Birmingham: lead
• Kigali University Teaching Hospital: collaborator
• Université d'Abomey-Calavi: collaborator

Study Sites (7)

University of Abomey-Calavi

Abomey-Calavi, Benin

Location

Tamale Teaching Hospital

Tamale, Ghana

Location

Christian Medical College (CMC) & Hospital, Ludhiana

Ludhiana, 141008, India

Location

Hospital Espanola Veracruz

Veracruz, 91700, Mexico

Location

Lagos University Teaching Hospital (Hub)

Lagos, Nigeria

Location

University Teaching Hospital of Kigali (Hub)

Kigali, Rwanda

Location

University of the Witwatersrand

Johannesburg, South Africa

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Pinkney

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Lillywhite

CONTACT

+44 (0)121 415 9103; r.e.lillywhite@bham.ac.uk

Divya Kapoor

CONTACT

+44 (0)121 415 9103; d.kapoor@bham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants should be randomised by a member of the research team who will not be performing the any aftercare, including trial-specific follow-up assessment(s). The follow-up assessor at 30 days will therefore be blinded to treatment allocation until after the completion of follow-up. Unless otherwise instructed by a research ethics committee, the operative notes should not include details of the specific intervention used.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic, outcome assessor blinded, stratified, international multi-centre, multi-arm multi-stage 2x2x2 factorial randomised controlled trial, with internal pilots. Strata are defined according to the anticipated category of wound contamination: (1) clean-contaminated and (2) contaminated or dirty.

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 20, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1); ME (1); RW (1); NG (1); BE (1); GH (1); ZA (1)