Sutureless Drain Securement Device for Skin Injury

Overseen By Renea Jennings, BS RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Unilateral drain, Tegaderm allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called K-Lock, designed to secure drains without stitches. The goal is to compare this sutureless device to the traditional method of using stitches to secure drains. It targets patients undergoing surgeries such as breast reconstruction, tummy tucks, or body contouring that require two or more drains. Eligible candidates are patients from the Department of Plastic and Reconstructive Surgery who can consent in English and are not allergic to Tegaderm Dressing. As an unphased trial, this study offers patients the chance to contribute to innovative surgical advancements that may enhance post-operative care.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications, so it's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this sutureless drain securement device is safe for skin injury?

Research has shown that the K-Lock, a device used to secure drains without stitches, has been safe in earlier studies. These studies found that the K-Lock remained in place as expected, with no failures. It also did not cause additional skin injuries, indicating its safety.

Patients reported greater satisfaction with the K-Lock compared to traditional methods. This feedback suggests that the device is both effective and comfortable to use.

Overall, evidence indicates that the K-Lock is well-tolerated, with no major safety concerns reported in the studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the K-Lock device for drain securement because it offers a sutureless solution, potentially reducing skin injury compared to traditional suture-based techniques. Unlike standard methods that involve stitching, which can cause irritation and increase the risk of infection, the K-Lock device aims to be less invasive and more comfortable for patients. By eliminating the need for sutures, this device could simplify the drain securement process, leading to faster recovery and improved patient outcomes.

What evidence suggests that the K-Lock device is effective for skin injury?

Research has shown that the K-Lock device can hold drains in place without stitches. In earlier studies, K-Lock secured drains more quickly and successfully kept them in place every time. Patients reported greater satisfaction with K-Lock compared to traditional methods. The device does not increase skin problems, making it a safer choice. In this trial, participants will be assigned to different arms to test the K-Lock device on either the left or right side, while the opposite side will use a suture-based technique. These findings suggest that K-Lock could be a better option for securing drains. ^{1 3 4 5 6}

Who Is on the Research Team?

Lisa David, MD MBA

Principal Investigator

Wake Forest University Health Sciences

Adam J Katz, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Able to sign English language Consent form

Patient of the Department of Plastic and Reconstructive Surgery

Exclusion Criteria

Allergy to Tegaderm Dressing

Patients with unilateral drain placement

Unable to sign English language consent form

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative

The novel suture-less prototype device will be described and/or demonstrated to the patients, and the rationale for its development will be explained. Written informed consent will be obtained.

1 day

1 visit (in-person)

Intraoperative

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.

Day of surgery

1 visit (in-person)

Postoperative

The time until drain removal will be recorded for both groups. Patients will complete a survey about their experience with the pertinent securement method/drain site.

Up to 10 days

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including inspection of device sites for signs of skin injury.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• K-Lock

Trial Overview 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.

How Is the Trial Designed?

Group I: B K-Lock right Experimental Treatment 1 Intervention

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

Group II: A K-Lock left Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

The proposed method for securing drainage and perfusion catheters eliminates the need for skin sutures, which enhances patient comfort and simplifies the procedure.

This technique effectively prevents catheter kinking and minimizes the risk of dislodgment during dressing changes, while still allowing for easy adjustments by the radiologist.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin fixation of drainage and perfusion catheters. A new method. Miller, DL.[2004]

The study evaluated a subcutaneously anchored sutureless system for securing central venous catheters across three clinical trials, showing favorable results in terms of efficacy and safety.

The device is particularly beneficial for specific patient groups, including neonates, children, cognitively impaired older patients, those with skin issues, and patients needing long-term catheterization, as it helps reduce the risk of catheter dislodgement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience of a subcutaneously anchored sutureless system for securing central venous catheters. Pittiruti, M., Scoppettuolo, G., Dolcetti, L., et al.[2019]

Op-Site skin closures were successfully used on 100 patients in major surgeries, showing excellent cosmetic results and maintaining wound-edge apposition when underlying layers were properly closed.

The use of Op-Site closures resulted in a low incidence of infection, faster application, and better patient satisfaction compared to traditional suturing methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a new product for sutureless skin closure. Westaby, S.[2018]

A survey of 51 neurosurgeons revealed that sutures are still the most common method for securing external drainage (ED) to the skin, despite known complications, with many surgeons underestimating the risk of pullout and infection.

Many neurosurgeons believe that the pediatric population may require different techniques or devices for securing ED, highlighting a potential gap in current practices and the need for further research to improve safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to Secure CSF External Drainage to the Skin: Hints from an International Survey and the Current Literature. Noya, C., Auricchio, AM., Massimi, L., et al.[2022]

The sutureless wound-closure device was tested on 150 patients, significantly reducing the time needed for skin closure and providing easy removal and satisfactory skin apposition.

This method not only eliminates the drawbacks of traditional sutures but also offers secure adhesion and serves as a protective splint, leading to highly satisfactory cosmetic results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new sutureless technique for skin closure. Hasson, HM., Nicoloff, D., Ford, CR., et al.[2019]

In a study of 211 non-tunneled hemodialysis catheters from 110 patients, the use of the GRIP-LOK securement device significantly reduced the risk of catheter-related bloodstream infections (CRBSI) compared to conventional sutures, with a hazard ratio of 0.17.

The findings suggest that GRIP-LOK is a safer option for securing hemodialysis catheters, potentially lowering CRBSI risk by suppressing catheter-exit infections and dislodgement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of sutureless securement on hemodialysis catheter-related bloodstream infection. Fujimoto, K., Iida, E., Kumano, S., et al.[2022]

In a study of 25 patients with limb avulsion injuries, the combination of vacuum sealing drainage (VSD) and skin reattachment resulted in a high skin survival rate of over 96% in most cases, demonstrating its efficacy in promoting healing.

The use of VSD effectively controlled wound infections and led to satisfactory outcomes in skin color, texture, and sensory function, indicating it is a safe and effective treatment method for avulsion injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of vacuum sealing drainage in treating large avulsion injuries of limbs]. Ye, Z., Zhan, BL., Zhan, YZ., et al.[2011]

In a study of 33 children with infected or contaminated wounds, the technique of skin closure over vessel loops resulted in no cases of recurrent infection or wound dehiscence within 30 days post-operation, indicating its efficacy in managing such wounds.

The use of vessel loops allowed for a median postoperative stay of just 1 day, suggesting that this minimally invasive approach not only reduces complications but also facilitates quicker recovery and easier wound maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Broad Utility of a Minimally Invasive Technique for Pediatric Wound Care: Simple and Effective. Steen, EH., Tuley, JM., King, A., et al.[2021]

Sutureless adhesive securement devices, like the Grip-Lok®, are recommended as best practice for vascular access due to their cost-effectiveness and reliability.

These devices use hypoallergenic medical adhesive, which minimizes skin irritation and offers a dependable alternative to traditional suturing methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Universal adhesive vascular access securement with Grip-Lok devices. Barton, A.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12185086/

First-in-human Testing of a Novel Sutureless Drain ... K-LOCK reduced drain securement time (P = 0.0008), had no securement failures, and showed higher patient satisfaction without increasing skin ...

2. clinicaltrial.be clinicaltrial.be/en/details/32350?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Evaluation of a Novel Sutureless Drain Securement Device... This study will evaluate the feasibility, safety and efficacy of a novel sutureless drain securement device (K-Lock) via direct comparison to suture-based ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/53/NCT05251753/Prot_SAP_000.pdf

Evaluation of a Novel Sutureless Drain Securement Device ... To evaluate the feasibility, safety and efficacy of a novel suture-less drain securement device (K-Lock) via direct comparison to suture-based techniques.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40552068/

First-in-human Testing of a Novel Sutureless Drain ... Results: No drain securement failure was encountered. The average duration of drain placement was 9 days. Securement of the K-LOCK was ...

5. ctv.veeva.com ctv.veeva.com/study/evaluation-of-a-novel-sutureless-drain-securement-device

Evaluation of a Novel Sutureless Drain Securement Device This study will evaluate the feasibility, safety and efficacy of a novel sutureless drain securement device (K-Lock) via direct comparison ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05251753?locStr=Winston-Salem,%20NC&country=United%20States&state=North%20Carolina&city=Winston-Salem&distance=50&term=drain&rank=1

Evaluation of a Novel Sutureless Drain Securement Device ... 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.