BACKGROUND AND PURPOSE:

• Early studies have suggested that routinely changing gloves and instruments before abdominal wound closure may reduce surgical site infections (SSIs) but more high quality evidence is needed
• The National Institute for Health and Care Research (NIHR) Global Research Health Unit on Global Surgery (The Lancet, 2022) tested whether a routine change of gloves and instruments before wound closure reduced abdominal SSI

METHODS:

• Multicenter, cluster randomized trial (ChEETAh trial)
• Setting
  • Seven low-income and middle-income countries (Benin, Ghana, India, Mexico, Nigeria, Rwanda, South Africa)
• Population
  • Adults and children undergoing emergency or elective abdominal surgery (excluding cesarean) for a clean–contaminated, contaminated, or dirty operation
• Intervention
  • Current practice: Local standard of care
  • Intervention: Routine change of gloves and instruments before wound closure for the whole scrub team
• Study design
  • Hospitals were randomly assigned to an intervention group
  • Masking
    • Site investigators and outcome assessors not masked
    • Patients masked to treatment allocation
  • Analysis was by intention to treat
• Sample size calculation
  • 90% power to detect a minimum reduction in the primary outcome from 16% to 12%
  • Requiring 12,800 participants from at least 64 clusters
• Primary outcome
  • SSI within 30 days after surgery using CDC criteria

RESULTS:

• Current practice: 42 hospitals (7157 patients) | Intervention: 39 hospitals (6144 patients)
  • Adults: 88.9%
  • Elective surgery: 46.0%
  • Clean–contaminated surgery: 60.8%
  • Contaminated–dirty surgery: 39.2%
• Risk for SSI was lower in the intervention group
  • Current practice: 18.9%
  • Intervention: 16.0%
  • Adjusted risk ratio (aRR) 0.87 (95% CI, 0.79 to 0.95); P=0.0032
• There was no evidence to suggest heterogeneity of effect across any of the prespecified subgroup analyses
• The authors did not anticipate or collect any specific data on serious adverse events

CONCLUSION:

• Changing gloves and instruments before abdominal wound closure reduced the risk for surgical site infection by 30% in a low- and middle-income hospital setting
• The authors state

The results of this trial demonstrably justify a change in global practice within operating theatres

The wide variety of patient and operation types included in ChEETAh makes the trial findings generalisable to most types of abdominal surgery, in most hospitals around the world 

Learn More – Primary Sources:

Routine sterile glove and instrument change at the time of abdominal wound closure to prevent surgical site infection (ChEETAh): a pragmatic, cluster-randomised trial in seven low-income and middle-income countries

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