Evaluation of a Novel Sutureless Drain Securement Device

Wake Forest University (WFU)

Status: Completed

Conditions: Skin Injury

Treatments: Device: K-Lock

Study type: Interventional

Funder types: Other

Identifiers

NCT05251753

IRB00080041

Details and patient eligibility

About

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

Full description

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Exclusion criteria

• Patients with unilateral drain placement
• Unable to sign English language consent form
• Allergy to Tegaderm Dressing

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

A K-Lock left

Experimental group

Description:

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

Treatment:

Device: K-Lock

B K-Lock right

Experimental group

Description:

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

Treatment:

Device: K-Lock