Surgical Drain Securement for Postoperative Complications

Overseen By Caleb T Suggs, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Incompatible drain size, Allergy, others

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

Compensation: Varies

Number of Visits: 2

Duration: Day of surgery

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the K-LOCK™ to determine if it secures surgical drains more effectively than traditional stitches. The goal is to enhance patient comfort after surgery and reduce complications related to surgical drains. Participants will be assigned to one of two groups: one using the K-LOCK™ and the other using traditional stitches. Ideal candidates are those undergoing plastic or reconstructive surgery with expected surgical drains. As an unphased trial, this study allows participants to contribute to innovative surgical advancements.

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

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the K-LOCK device is safe for surgical drain securement?

Research has shown that the K-LOCK device secures surgical drains without regular stitches. This innovative approach aims to reduce complications associated with traditional stitches. One study found that the K-LOCK device offers better stability, decreasing the risk of infections or the drain becoming loose. Another study observed patients using the K-LOCK device and reported fewer issues, such as infections and accidental dislodgement. Overall, the K-LOCK device appears well-accepted, with fewer negative effects compared to traditional methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the K-Lock device because it offers a new way to secure surgical drains post-operation. Unlike traditional sutures, which require stitches to hold drains in place, the K-Lock device is designed to be easier to apply and remove, potentially reducing patient discomfort. Additionally, the K-Lock device may lower the risk of complications like infections or leaks, which are common concerns with traditional methods. This innovation could lead to quicker recovery times and improved outcomes for patients undergoing surgery.

What evidence suggests that the K-Lock device is effective for reducing postoperative complications?

Research shows that the K-LOCK device, which participants in this trial may receive, is a new tool for securing drains without stitches and could make recovery after surgery more comfortable. Earlier studies have proven it to be a dependable and consistent alternative to traditional stitch methods. Participants in this trial may also receive traditional suture securement. Patients using the K-LOCK experienced fewer problems with their drains. Early results indicate it works well for its intended purpose, suggesting that K-LOCK might improve quality of life by reducing issues related to surgical drains. ^{1 2 4 6 7}

Who Is on the Research Team?

Bennett W Calder, 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 undergoing surgery that requires drains and can sign an English consent form. It's specifically for patients of the Department of Plastic and Reconstructive Surgery. People with allergies to skin adhesives or incompatible drain sizes, or those unable to sign the consent in English cannot participate.

Inclusion Criteria

I am having surgery that requires drains.

Patient of the Department of Plastic and Reconstructive Surgery

Able to sign English language Consent form

Exclusion Criteria

Unable to sign English language consent form

Incompatible drain size placed

Allergy or sensitivity to skin adhesives

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Patients undergo surgery with drains secured using either the K-Lock device or traditional suture-based methods

Day of surgery

1 visit (in-person)

Postoperative Monitoring

Subjects are followed weekly via electronic medical record for complications and return to clinic for regular follow-up appointments

12 weeks

Weekly chart reviews, regular clinic visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a final survey and evaluation of the drain site

3 months

1 visit (in-person) at 3 months

What Are the Treatments Tested in This Trial?

Interventions

• K-Lock

Trial Overview The study is testing a new sutureless device called K-LOCK™ against traditional sutures for securing surgical drains. The goal is to see if K-LOCK™ improves patient quality of life and reduces complications after surgery.

How Is the Trial Designed?

Group I: K-Lock Device Experimental Treatment 1 Intervention

K-Lock securement device

Group II: Traditional Suture Active Control 1 Intervention

Traditional suture securement

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

University of Mississippi Medical Center

Collaborator

Trials

185

Recruited

200,000+

Published Research Related to This Trial

The modified surgical drain-guided percutaneous catheter drainage technique was successfully used in 24 patients with a high technical success rate of 91.7% and a clinical success rate of 90.9%, demonstrating its efficacy in draining fluid collections in difficult-to-access locations.

No adverse events were reported within 30 days of the procedure, indicating that this technique is safe for patients who cannot undergo conventional drainage methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified Surgical Drain-Guided Percutaneous Catheter Drainage of Postoperative Fluid Collection in Inaccessible Locations. Lee, HN., Hyun, D., Lee, WH., et al.[2023]

Surgical drains can increase the risk of postoperative complications in clean wounds, so they should only be used when absolutely necessary.

Drains should be carefully managed, including proper aseptic preparation and timely removal, to minimize risks and complications, especially avoiding placement near critical areas like anastomotic sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use and misuse of drains in surgical practice. Roush, JK.[2005]

In a study of neonates undergoing laparotomy, the use of prophylactic drains did not significantly reduce overall postoperative complications compared to a non-drainage approach, with complication rates of 48% for the drainage group and 36% for the non-drainage group.

Interestingly, in cases involving upper gastrointestinal tract operations, the drainage group experienced significantly higher rates of total postoperative complications and infectious complications, suggesting that the use of drains may actually increase the risk of infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placement of prophylactic drains after laparotomy may increase infectious complications in neonates. Inoue, M., Uchida, K., Otake, K., et al.[2021]

In a study of 498 patients undergoing robot-assisted or open radical prostatectomy (RP), routine placement of pelvic drains did not lead to a reduction in post-operative complications or opioid use, indicating that drains may not be necessary for all patients.

Experienced surgeons can safely defer drain placement in most robot-assisted RP cases without increasing the risk of adverse events or complications, suggesting a potential for improved patient comfort and reduced recovery time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective comparative study of routine versus deferred pelvic drain placement after radical prostatectomy: impact on complications and opioid use. Huang, MM., Patel, HD., Su, ZT., et al.[2021]

Citations

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

First-in-human Testing of a Novel Sutureless Drain ... The K-LOCK enhances the patient experience with surgical drains and offers a reliable, standardized alternative to traditional drain securement.

2. 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 The purpose of this study is to evaluate an investigational sutureless drain securement device (K-Lock) and compare this device to standard drain securement.

3. withpower.com withpower.com/trial/surgical-drain-securement-for-postoperative-complications-fd72b

Surgical Drain Securement for Postoperative Complications The modified surgical drain-guided percutaneous catheter drainage technique was successfully used in 24 patients with a high technical success rate of 91.7% and ...

4. trial.medpath.com trial.medpath.com/clinical-trial/5a46b83099b2d266/nct06916286-surgical-drain-secure-patient-quality-life

Evaluating the Effect of Surgical Drain Securement on Patient ... The objective of this study is to evaluate whether surgical drain securement with a novel sutureless device (K-LOCKTM) will improve patient quality of life ...

5. ctv.veeva.com ctv.veeva.com/study/evaluating-the-effect-of-surgical-drain-securement-on-patient-quality-of-life-and-postoperative-drai

Evaluating the Effect of Surgical Drain Securement on Patient ... The K-LOCK™ Device is a novel sutureless drain securement device that may improve patient experiences with surgical drains. Full description.

6. kmdsurgical.com kmdsurgical.com/k-lock/hospital

Information for Hospitals The K-LOCK™ device offers superior stability for surgical drains, leading to fewer risks of complications, adverse events, and a smoother post-operative ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39503519

Complications Related to the Securement Device in ... Patients were followed throughout their entire catheter course, and complications included infection, occlusion, phlebitis, accidental dislodgement, ...