Arrhythmias & electrophysiology

Iodinated Adhesive Drapes for Repeat Cardiac Implantable Device Implantation: A Randomized Clinical Trial

JAMA CardiolPublished Randomised controlled trial

Primary result · Pocket-swab culture positivityResult — go to the resultRelative risk reduction 0.50 95% CI 0.24–0.75

Authors' conclusion

In this randomized clinical trial, the use of iodine-impregnated drapes during repeat CIED implantation resulted in reduction in swab culture positivity and 1-year CIED infection rates.

Study context

Population
Patients undergoing repeat procedures on the same cardiac implantable electronic device (CIED) pocket189 + 195 analysed
Participants
418 patients
Comparison
Iodine-impregnated adhesive drape vs no drape
  • Drapen = 210
  • No-drapen = 208reference
Primary endpoint
End-of-procedure pocket-swab culture positivity
Methodological detailssingle-blinded, single-centre, 1:1 randomisation
  • Single-blinded
  • Single-centre
  • 1:1 randomisation

Primary result

Pocket-swab culture positivity

Relative risk reduction

0.50

95% CI 0.24–0.75

P = 0.005

Events by treatment group

Drapevs No-drape
relative risk reduction 0.50 (95% CI 0.24–0.75); P = 0.005

As reported in the abstract

Further findings

OutcomeOR (95% CI)P value
CIED infection by swab result (positive vs negative swabs)2 of 59 (3.4%) vs 2 of 325 (0.6%)5.67 (0.78–41.04)P = 0.08
OutcomeDrapeNo-drapeP value
Adjudicated CIED infections0 events1.9%P = 0.02

Original publication

Iodinated Adhesive Drapes for Repeat Cardiac Implantable Device Implantation: A Randomized Clinical Trial. JAMA Cardiol. Published 1 October 2025. doi:10.1001/jamacardio.2025.2835

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