Trial reportJAMA cardiology2025
Iodinated Adhesive Drapes for Repeat Cardiac Implantable Device Implantation: A Randomized Clinical Trial.
Trial report in JAMA cardiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04591366 (Barrier-Protect Study), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Barrier-Protect Study: Do Barrier Dressings Reduce Device Infection: a Pilot, Randomized Controlled Trial
Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Antimicrobial Pocket Flush and Cardiac Implantable Electronic Device Infection: Meta-Analysis of Real-World Studies.Pacing and clinical electrophysiology : PACE · 2026Pooled it
- Evidence-Based Strategies for the Prevention of Cardiac Implantable Electronic Device Infections: An Up-to-Date Narrative Review.Medicina (Kaunas, Lithuania) · 2026Review
- Addressing Complications in Cardiac Implantable Electronic Devices: A Guideline to Prevention of CIED Infection.Journal of cardiovascular development and disease · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
25 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Importance: One potential pathophysiological mechanism for cardiac implantable electronic device (CIED) infections is pocket contamination during the implantation procedure. Preventing contamination at this stage may significantly reduce the risk of infections. Objective: To determine whether the application of an intraoperative adhesive iodine-impregnated drape would reduce the rate of end-of-procedure pocket-swab positivity and subsequent CIED infections. Design, Setting, and Participants: This was a prospective, double-armed, single-blinded, randomized clinical trial, conducted from November 2020 to May 2024. Patients, the staff performing the swabs, and the microbiologists were blinded to group assignments. This was a single-center study that included patients undergoing repeat procedures on the same device pocket. These patients were randomized in a 1:1 ratio to either the iodine-impregnated drape group or the control group. Intervention: Application of an iodine-impregnated drape at the beginning of the procedure. Main Outcomes and Measures: The primary end point was end-of-procedure pocket-swab culture positivity. Results: A total of 418 patients were randomized (210 to the drape group and 208 to the no-drape group). The final analysis included 189 patients in the drape group and 195 patients in the no-drape group, with both groups well balanced in demographics. In the drape group, 143 participants were male (75.7%), and mean (SD) age was 73.9 (12.1) years; in the no-drape group, 140 were male (71.8%), and mean (SD) age was 73.2 (12.6) years. Pocket-swab culture positivity was found in 19 of 189 patients (10.1%) in the drape group compared with 40 of 195 patients (20.5%) in the no-drape group (relative risk reduction [RRR], 0.50; 95% CI, 0.24-0.75; P = .005). Adjudicated CIED infections occurred in 4 of 195 patients (1.9%) in the no-drape group vs 0 of 189 in the drape group (P = .02). CIED infections were observed in 2 of 59 patients (3.4%) with positive swabs and in 2 of 325 patients (0.6%) with negative swabs (odds ratio, 5.67; 95% CI, 0.78-41.04; P = .08). Conclusions and Relevance: 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. This is a simple and cost-effective intervention to reduce CIED pocket contamination and subsequent infections. Trial Registration: ClinicalTrials.gov Identifier: NCT04591366.
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