Evaluation of a Novel Sutureless Drain Securement Device

Skin Injury Clinical Trial

Official title:

Evaluation of a Novel Sutureless Drain Securement Device (K-Lock Device) and Comparison to Standard Suture-based Drain Securement Techniques

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05251753
• Other study ID #: IRB00080041
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: Wake Forest University Health Sciences
• Contact: Renea Jennings, BS RN
• Phone: 3367166709
• Email: rjenning[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the feasibility, safety and efficacy of a novel suture-less drain securement device (K-Lock) via direct comparison to suture-based techniques. In this study the suture-less drain securement device will be compared to the use of sutures to secure drains. One will be secured with the K-Lock and the other will be secured with sutures.

Description:

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. Randomization will occur before study initiation with group A or group B being assigned to a study enrollment number.

Preoperatively:

The novel suture-less prototype device will be described and/or demonstrated to the patients, and the rationale for its development will be explained. They will have opportunity to ask questions and then they will be invited to participate in the study.

Written informed consent will be obtained.

Intraoperatively:

Surgical drains will be placed per the usual routine of the surgeon. Definitive drain fixation will occur when all of the pertinent incisions are closed and dressed. At that time, each drain will be secured according to the randomization scheme.

The amount of time it takes to secure and dress each drain will be recorded using a time-stamped video (e.g. iphone).

Postoperatively:

The time until drain removal will be recorded for both groups.

On postoperative visit(s) on which a drain is removed, patients will complete a survey about their experience with the pertinent securement method/drain site.

Feasibility and ease of use of the novel drain device will be evaluated by evaluation of video recordings, qualitative feedback obtained from surgeons and/or O.R staff and nurses that handle and observe use of the device.

Safety of the novel drain device will be evaluated by inspecting device sites for signs of skin injury at each office visit and at the time of drain removal, including photographs of drain sites immediately before and after removal. It will also be assessed by feedback obtained in the patient surveys.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Skin Injury

Intervention

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.

Locations

Country	Name	City	State
United States	Atrium Health Wake Forest Baptist	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time it takes to secure and dress each drain	Time it takes to secure and dress each drain will be evaluated 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	Ease of Use	Ease of Use will be evaluated by data recorded on the "System Usability Scale" given to OR staff. Data is qualitative on a scale from 1-5.	Day of Surgery
Secondary	Skin Injury	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.	Day of surgery to day of drain removal, estimated average = 10 days