Evaluation of a Novel Sutureless Drain Securement Device

NCT05251753 | Completed Results FDA Device

• 1 other identifier: IRB00080041
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Skin Injury

Keywords

drain; suture; body contouring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Ease of Use

  Day of Surgery

• Skin Injury

  On Average Day 10

Study Arms (2)

A K-Lock left

EXPERIMENTAL

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

Device: K-Lock

B K-Lock right

EXPERIMENTAL

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

Device: K-Lock

Interventions

K-Lock 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.

A K-Lock left; B K-Lock right

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

Results Point of Contact

• Title: Caleb Suggs
• Organization: Wake Forest School of Medicine

csuggs@wakehealth.edu

3367164171

Study Officials

• Lisa David, MD MBA

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Adam J Katz, MD

  Wake Forest University Health Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: February 23, 2022
• Study Start: March 7, 2022
• Primary Completion: March 6, 2025
• Study Completion: March 6, 2025
• Last Updated: May 20, 2025
• Results First Posted: May 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)