← Back to Search

Device

Sutureless Drain Securement Device for Skin Injury

N/A

Recruiting

Led By Lisa David, MD MBA

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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, brachioplasty, thighplasty)

Age 18 or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day of surgery

Awards & highlights

Study Summary

This trial will compare the safety and effectiveness of a new suture-less drain securement device to the use of sutures.

Who is the study for?

This trial is for adults over 18 who are patients at the Department of Plastic and Reconstructive Surgery, can consent in English, and are having surgeries like breast reconstruction or body contouring that require two or more drains. It's not for those allergic to Tegaderm dressing or with only one drain.Check my eligibility

What is being tested?

The study tests a new sutureless device called K-Lock against traditional sutures for securing surgical drains. The goal is to see if K-Lock is as safe and effective as sutures without needing stitches.See study design

What are the potential side effects?

Potential side effects may include skin irritation or injury at the site where the drain is secured, either from the K-Lock device itself or from the sutures used in traditional methods.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having surgery that requires 2 or more drains, such as breast reconstruction or a tummy tuck.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day of surgery to day of drain removal, estimated average = 10 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day of surgery to day of drain removal, estimated average = 10 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and day of surgery to day of drain removal, estimated average = 10 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time it takes to secure and dress each drain

Secondary outcome measures

Ease of Use

Skin Injury

Trial Design

2Treatment groups

Experimental Treatment

Group I: B K-Lock rightExperimental Treatment1 Intervention

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

Group II: A K-Lock leftExperimental Treatment1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,243 Previous Clinical Trials

1,004,686 Total Patients Enrolled

Lisa David, MD MBAPrincipal InvestigatorWake Forest University Health Sciences

Adam J Katz, MDStudy DirectorWake Forest University Health Sciences

Media Library

K-Lock (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05251753 — N/A

Skin Injury Research Study Groups: A K-Lock left, B K-Lock right

Skin Injury Clinical Trial 2023: K-Lock Highlights & Side Effects. Trial Name: NCT05251753 — N/A

K-Lock (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05251753 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current size of the patient cohort involved in this research?

"Affirmative. According to records on clinicaltrials.gov, this experiment is actively trying to recruit participants and was first uploaded on March 7th 2022 before being updated April 4th of the same year. The research team needs a total of 10 patients from one site for their study."

Answered by AI

Are there currently vacancies in this clinical research endeavor?

"Clinicaltrials.gov reveals that this trial is presently recruiting patients; the posting for recruitment was first launched on March 7th 2022, with recent changes made to it as recently as April 4th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of a Novel Sutureless Drain Securement Device

2022. "Evaluation of a Novel Sutureless Drain Securement Device". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05251753.