The purpose of this study is to evaluate an investigational sutureless drain securement device (K-Lock) and compare this device to standard drain securement.
This study will evaluate the feasibility, safety and efficacy of a novel sutureless drain securement device (K-Lock) via direct comparison to suture-based techniques. In this study the sutureless drain securement device will be compared to the use of sutures to secure drains. Patients will be randomized to either A) left side K-Lock with right side suture-based technique or B) right side K-Lock with left side suture-based technique.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
22
Patients will be randomized to either A) left side K-Lock with right side suture-based technique or B) right side K-Lock with left side suture-based technique.
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Time it Takes to Secure and Dress Each Drain in Totality
Time it takes to secure and dress each drain will be evaluated in totality by evaluation of video recordings to record timestamps and documented on "K-Lock Study Outcomes" tool. This will help determine the feasibility of using this device.
Time frame: Day of Surgery
Ease of Use
For each participant, the surgeon will evaluate the K-Lock device ease of use of on a scale from 1-5. A higher score indicates greater ease of use.
Time frame: Day of Surgery
Skin Injury
Skin Injury will be evaluated by inspecting device sites for instances of skin injury at each office visit and will be recorded on "K-Lock Study Outcomes" tool. Skin Injury will also be evaluated by quantitative feedback obtained in the "Drain Securement Survey" given to patients post-operatively. Number of Injuries for all K-Lock sites will be reported as a total.
Time frame: On Average Day 10
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