Evaluation of a Novel Sutureless Drain Securement Device

Last updated: May 6, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Completed

Phase

N/A

Condition

Pressure Ulcer

Treatment

K-Lock

Clinical Study ID

NCT05251753
IRB00080041
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Patients with unilateral drain placement

  • Unable to sign English language consent form

  • Allergy to Tegaderm Dressing

Study Design

Total Participants: 22
Treatment Group(s): 1
Primary Treatment: K-Lock
Phase:
Study Start date:
March 07, 2022
Estimated Completion Date:
March 06, 2025

Study 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.

Connect with a study center

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

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