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Clinical Trials in India / NCT06465901
Starting soon Not applicable

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

NCT06465901 · tracked via the Priya Life Science India tracker
Sponsor
University of Birmingham
Phase
Not applicable
Started
2024-09-01
Last updated
2024-06-20

Condition(s) studied

Surgical Site Infection

Investigational drug(s) / intervention(s)

Chlorhexidine Gluconate 2.0% to 4.0% (e.g. Hibiscrub) preoperative showerIntraoperative wound wash (e.g. Granudacyn)DACC surgical wound dressing (e.g. Leukomed Sorbact)

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

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

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

Study 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).

Eligibility

Sex
ALL
Min age
5 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
University of Abomey-Calavi Abomey-Calavi Benin
Tamale Teaching Hospital Tamale Ghana
Christian Medical College (CMC) & Hospital, Ludhiana Ludhiana India
Hospital Espanola Veracruz Veracruz Mexico
Lagos University Teaching Hospital (Hub) Lagos Nigeria
University Teaching Hospital of Kigali (Hub) Kigali Rwanda
University of the Witwatersrand Johannesburg South Africa

More University of Birmingham trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06465901 on ClinicalTrials.gov ↗ ← All trials in India