NCT05251753

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Skin Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-07
• Primary completion: 2025-03-06
• Completion: 2025-03-06
• First posted: 2022-02-23
• Last updated: 2025-05-20
• Results posted: 2025-05-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study