Evaluation of a Novel Sutureless Drain Securement Device

Not Applicable

Completed

• Conditions: Skin Injury
• Interventions: Device: K-Lock

• Registration Number: NCT05251753
• Lead Sponsor: Wake Forest University Health Sciences

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.

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 Timeline

• Study First Submitted: 2022-02-11
• Study First Submitted QC: 2022-02-11
• Study First Posted: 2022-02-23
• Study Start: 2022-03-07
• Status Verified: 2025-01
• Primary Completion: 2025-03-06
• Study Completion: 2025-03-06
• Results First Submitted: 2025-03-07
• Results First Submitted QC: 2025-05-06
• Last Update Submitted: 2025-05-06
• Results First Posted: 2025-05-20
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A K-Lock left	K-Lock	A) left side K-Lock with right side suture-based technique
B K-Lock right	K-Lock	B) right side K-Lock with left side suture-based technique.

Primary Outcome Measures

Name	Time	Method
Time it Takes to Secure and Dress Each Drain in Totality	Day of Surgery	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.

Secondary Outcome Measures

Name	Time	Method
Ease of Use	Day of Surgery	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.
Skin Injury	On Average Day 10	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.

Trial Locations

Locations (1)

Atrium Health Wake Forest Baptist; 🇺🇸 Winston-Salem, North Carolina, United States