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

To evaluate the feasibility, safety and efficacy of a novel suture-less drain securement device (K-Lock) via direct comparison to suture-based techniques. In this study the suture-less drain securement device will be compared to the use of sutures to secure drains. One will be secured with the K-Lock and the other will be secured with sutures.

Study Overview

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

Detailed Description

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. Randomization will occur before study initiation with group A or group B being assigned to a study enrollment number.

Preoperatively:

The novel suture-less prototype device will be described and/or demonstrated to the patients, and the rationale for its development will be explained. They will have opportunity to ask questions and then they will be invited to participate in the study.

Written informed consent will be obtained.

Intraoperatively:

Surgical drains will be placed per the usual routine of the surgeon. Definitive drain fixation will occur when all of the pertinent incisions are closed and dressed. At that time, each drain will be secured according to the randomization scheme.

The amount of time it takes to secure and dress each drain will be recorded using a time-stamped video (e.g. iphone).

Postoperatively:

The time until drain removal will be recorded for both groups.

On postoperative visit(s) on which a drain is removed, patients will complete a survey about their experience with the pertinent securement method/drain site.

Feasibility and ease of use of the novel drain device will be evaluated by evaluation of video recordings, qualitative feedback obtained from surgeons and/or O.R staff and nurses that handle and observe use of the device.

Safety of the novel drain device will be evaluated by inspecting device sites for signs of skin injury at each office visit and at the time of drain removal, including photographs of drain sites immediately before and after removal. It will also be assessed by feedback obtained in the patient surveys.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Renea Jennings, BS RN; Phone Number: 3367166709; Email: rjenning@wakehealth.edu
• Study Contact Backup: Name: Caleb T Suggs, BS; Phone Number: 3367134339; Email: csuggs@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Atrium Health Wake Forest Baptist
      • Contact: Caleb T Suggs, BS; Phone Number: 3367134339; Email: csuggs@wakehealth.edu
      • Contact: Renea Jennings, BS RN; Phone Number: 336-716-6709; Email: rjenning@wakehealth.edu
      • Principal Investigator: Lisa David, MD MBA
      • Sub-Investigator: Adam J Katz, MD

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: Device Feasibility
• 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	Time it takes to secure and dress each drain will be evaluated 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	Ease of Use will be evaluated by data recorded on the "System Usability Scale" given to OR staff. Data is qualitative on a scale from 1-5.	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.	Day of surgery to day of drain removal, estimated average = 10 days

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 (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 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 (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

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