Evaluation of a Novel Sutureless Drain Securement Device

Evaluation of a Novel Sutureless Drain Securement Device (K-Lock Device) and Comparison to Standard Suture-based Drain Securement Techniques

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

Study Overview

• Status: Completed
• Conditions: Skin Injury
• Intervention / Treatment: Device: K-Lock

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A K-Lock left; A) left side K-Lock with right side suture-based technique	Device: 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.
Experimental: B K-Lock right; B) right side K-Lock with left side suture-based technique.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day of Surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	On Average Day 10

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Lisa David, MD MBA, Wake Forest University Health Sciences; Study Director: Adam J Katz, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): March 6, 2025
• Study Completion (Actual): March 6, 2025

Study Registration Dates

• First Submitted: February 11, 2022
• First Submitted That Met QC Criteria: February 11, 2022
• First Posted (Actual): February 23, 2022

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: suture; body contouring; drain
• Other Study ID Numbers: IRB00080041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No