Barrier-Protect Study | NCT04591366 | Trialant

Barrier-Protect Study | NCT04591366 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator	Standard skin prep prior to procedure will be performed and an adhesive iodine-infused barrier dressing will be applied post procedure but prior to taking the culture swab and closing the incision.	Other: Barrier dressing
Intervention	Experimental	Standard skin prep prior to procedure plus an adhesive iodine-infused barrier dressing prior to incision, post procedure a culture swab will be taken and the incision closed.	Other: Barrier dressing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Barrier dressing	Other	A barrier dressing will be applied either pre or post implant prior to a culture swab and closing the incision.	Control Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
End of surgery pocket swab culture positivity	To investigate end of procedure pocket swab culture positivity as a potential surrogate marker of device infection	one month post procedure

Secondary Outcomes

Measure	Description	Time Frame
CIED infection, defined as in the recent PADIT trial	Pocket infection: Nosocomial surgical site infection will be defined according to the 2008 National Healthcare Safety Network (NHSN) and US CDC definitions for superficial and deep surgical site infections (30) Endocarditis will be diagnosed according to the Modified Dukes' criteria (31). These were adapted by Klug D et al. to diagnose endocarditis in patients with implantable cardiac devices (32). Bloodstream infections will be defined according to 2008 NHSN and US CDC definitions for Primary bloodstream infections (33)

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40864462	Derived	Aydin A, Golian M, Klein A, Redpath C, Davis DR, Ramirez FD, Nair GM, Green MS, Sadek M, Nery PB, Hansom SP, Al Hinai G, Weng W, Berbenetz N, Thibert MJ, Salmeen Y, Martow E, Tan LW, Almidani G, Alshehri A, Alzahrani A, Alharbi F, Corrales-Medina V, Wells GA, Birnie DH. Iodinated Adhesive Drapes for Repeat Cardiac Implantable Device Implantation: A Randomized Clinical Trial. JAMA Cardiol. 2025 Oct 1;10(10):1016-1023. doi: 10.1001/jamacardio.2025.2835.