The primary objective is to demonstrate a better degree of healing at the incision site and a decrease in erosion with CanGaroo compared to control patients (no envelope, CIED alone).
A single-center, prospective, randomized, post-market study of patients undergoing implantation of a pacemaker, ICD, or S-ICD with or without CanGaroo using the same hydration solution. Twenty patients, randomized 1:1 for 10 in the treatment group and 10 in the control group, shall be enrolled. Follow-up visits include post-op and 3-months following the implantation procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
CIED ECM envelope
Healing at incision site
Improved incision site healing for the CanGaroo group
Time frame: 3 months post CIED implantation
QOL Survey
Patient assessment via Quality of Life Survey
Time frame: 3 months post CIED implantation
Vascular Tissue Layer
Ultrasound measurement of vascular tissue layer
Time frame: 3 months post CIED implantation
Skin Fold Test
Skin fold test measurement for tissue thickness
Time frame: 3 months post CIED implantation
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