Evaluation of a Novel Sutureless Drain Securement Device

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-07

Study Completion Date

2025-03-06

Brief Summary

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The purpose of this study is to evaluate an investigational sutureless drain securement device (K-Lock) and compare this device to standard drain securement.

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Detailed Description

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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.

Conditions

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Skin Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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A K-Lock left

A) left side K-Lock with right side suture-based technique

Group Type EXPERIMENTAL

K-Lock

Intervention Type DEVICE

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.

B K-Lock right

B) right side K-Lock with left side suture-based technique.

Group Type EXPERIMENTAL

K-Lock

Intervention Type DEVICE

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.

Interventions

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K-Lock

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 18 or older
* Patient of the Department of Plastic and Reconstructive Surgery
* Able to sign English language Consent form
* Undergoing any of the following procedures requiring placement of 2 or more drains (preferably bilateral) including: Breast reconstruction, Bilateral Breast Reduction, Abdominoplasty, Body Contour surgery (e.g. panniculectomy, brachiplasty, thighplasty)