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

Trial Summary

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 data supports the effectiveness of the treatment K-Lock for reducing postoperative complications?

The research suggests that early removal of surgical drains can reduce the risk of infections after surgery, which implies that secure and effective drain management, like with K-Lock, could help prevent complications. Additionally, techniques to prevent drain-related issues, such as retained fragments, highlight the importance of secure drain placement and removal. ^{1 2 3 4 5}

Is the surgical drain securement method safe for humans?

A new drainage system called Robinson showed no complications in general surgery use, indicating it is safe. Additionally, patient-performed at-home surgical drain removal was found to be safe and feasible after certain surgeries. ^{1 2 6 7 8}

How is the K-Lock treatment different from other treatments for surgical drain securement?

The K-Lock treatment is unique because it focuses on securely fastening surgical drains to prevent complications, which is not typically addressed by other treatments. This approach may reduce the risk of drains becoming dislodged or causing additional complications, unlike traditional methods that often require careful monitoring and management. ^{1 9 10 11 12}

What is the purpose of this trial?

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 and reduce postoperative drain-related complications compared to drain securement with traditional suture-based methods. The K-LOCK™ Device is a novel sutureless drain securement device that may improve patient experiences with surgical drains.

Research Team

Bennett W Calder, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patient-performed at-home surgical drain removal is safe and feasible following hernia repair and abdominal wall reconstruction. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Early removal of prophylactic drains reduces the risk of intra-abdominal infections in patients with pancreatic head resection: prospective study for 104 consecutive patients. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Retained broken wound drains: a preventable complication. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Modified Surgical Drain-Guided Percutaneous Catheter Drainage of Postoperative Fluid Collection in Inaccessible Locations. [2023]

5. Germany 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. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

[A new method of gravity drainage]. [2006]

7. Germany pubmed.ncbi.nlm.nih.gov

Placement of prophylactic drains after laparotomy may increase infectious complications in neonates. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

[The influence of the drain suction in knee arthroplasty]. [2019]

9. Spain pubmed.ncbi.nlm.nih.gov

Minimally invasive retrieval of a retained Jackson--Pratt drainage tube using the Sachse urethrotome. [2012]

10. United States pubmed.ncbi.nlm.nih.gov

Closed suction wide area drainage. [2009]

11. England pubmed.ncbi.nlm.nih.gov

Knotted drainage tube: An unusual postoperative complication. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

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