Evaluation of a Novel Sutureless Drain Securement Device

Wake Forest University (WFU)

Status: Enrolling

Conditions: Skin Injury

Treatments: Device: K-Lock

Study type: Interventional

Funder types: Other

Identifiers

NCT05251753

IRB00080041

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

A K-Lock left

Experimental group

Description:

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

Treatment:

Device: K-Lock

B K-Lock right

Experimental group

Description:

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

Treatment:

Device: K-Lock