Self-Drain Removal for Hernia

(SDR Trial)

TH
GS
Overseen ByGreg Scarola, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether patients can safely remove surgical drains at home after ventral hernia repair. It compares individuals who use online video training for self-removal with those who have drains removed by a doctor during a clinic visit. The goal is to determine if self-removal is as safe and effective as the standard method. Individuals who recently underwent ventral hernia repair with a subcutaneous drain and have access to online instructions might be suitable candidates. As an unphased study, this trial provides a unique opportunity to contribute to research that could simplify post-surgical care for future patients.

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 self-drain removal is safe for patients?

Research shows that patients can safely remove their surgical drains at home. Studies have found that self-removal allows for quicker removal and can be done safely. This eliminates the need for clinic visits to manage drains. This method has been tested and integrates smoothly into patients' daily routines. Evidence suggests that with proper training and guidance, patients can handle this process safely on their own.12345

Why are researchers excited about this trial?

Researchers are excited about the self-drain removal technique for hernia patients because it empowers patients to manage their recovery at home, potentially reducing the need for clinic visits. While the standard of care involves a healthcare provider removing the drain during a clinic visit, this new approach uses an online video to guide patients through the process. This method not only offers convenience but also promotes patient independence, which could lead to a more efficient use of healthcare resources and improve patient satisfaction.

What evidence suggests that self-drain removal is effective for ventral hernia repair?

This trial will compare self-drain removal at home with standard drain removal during a clinic visit. Research has shown that patients can safely remove their surgical drains at home after hernia repair. One study found that patients who removed their drains at home did so sooner—about 9 days—compared to those who waited for a clinic visit, which took about 13 days. This suggests that home removal may be more convenient without adding any risks. Another study found that home drain removal not only benefits patients but also saves time and resources for healthcare providers and systems. Overall, these findings support the idea that teaching patients to remove drains at home is both safe and effective.12356

Who Is on the Research Team?

TH

Todd Heniford, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have had a ventral hernia repair and are capable of learning to remove their own surgical drains at home. It's not clear what the exclusion criteria are, but typically they would exclude those with conditions that might complicate self-removal or follow-up.

Inclusion Criteria

Anticipated Centers for Disease Control and Preventions (CDC) 1&2 wound class
I have a drain placed under my skin.
I am scheduled for elective surgery to repair a ventral hernia.

Exclusion Criteria

I am scheduled for other medical procedures.
I currently have a mesh infection.
Patients who do not have access to the online training video
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants receive training on self-drain removal through a detailed online video and practice on a model

1 hour
1 visit (virtual)

Treatment

Participants either self-remove the drain at home or have it removed during a clinic visit by a provider

2 weeks

Follow-up

Participants are monitored for safety, effectiveness, and satisfaction after drain removal

30 days

What Are the Treatments Tested in This Trial?

Interventions

  • Self-drain removal
Trial Overview The study is testing if patients can safely remove their own surgical drains after a ventral hernia repair instead of having them removed by a healthcare provider in a clinic. Participants will be randomly assigned to either try self-removal at home or receive standard care.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Self-drain removal trainingExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

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

In a study involving 25 patients undergoing inguinal hernia repair, the use of short-term subcutaneous drainage significantly reduced the occurrence of early inflammatory and bleeding complications compared to a control group.
This suggests that implementing subcutaneous drainage may enhance patient safety and recovery outcomes following hernia surgery.
[Short-term drainage in inguinal hernia repair].Devis, A., Janne, P.[2007]
The report discusses a method for safely detaching an intra-abdominally fixed T-drain using a ring stripper, which allowed for surgical removal without complications.
This technique may provide a less invasive option for managing T-drains, potentially improving patient outcomes by reducing the need for more extensive surgical procedures.
[Removal of a fixed T-drain following detachment by a ring stripper].Schild, H., Schmidt, HD., Eckmann, A.[2006]
In a study of 80 patients undergoing elective hernia repair, the new slit-suction drainage required significantly less traction power for removal (25 pounds) compared to the Redon-suction drainage (226 pounds), indicating it is easier to remove.
Patients with the slit drain reported much less pain during removal, while those with the Redon drain consistently experienced pain, suggesting that the slit drain is a more comfortable option for post-operative care.
[Slit drainage--progress in drainage treatment after herniotomy].Graupe, F., Böhm, B., Hucke, HP., et al.[2006]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36167625/
Patient-performed at-home surgical drain removal is safe ...Conclusions: Patient-performed at-home drain removal is safe and allows for more timely drain removal.
Investigating the Feasibility and Outcomes of Patient Self ...This study will show that patient self-drain removal benefits the patients, the providers, and healthcare system without compromising patient ...
Optimizing Surgical Drain Removal: A Narrative Review ...Surgical drains remain a common adjunct in general surgery to prevent fluid collections and detect early postoperative complications.
Patient-Performed At-Home Surgical Drain Removal after ...Patients who had their drains removed at home were more likely to have it done sooner (9 days as opposed to 13 days for in-clinic, P< 0.001).
Optimizing Surgical Drain Removal: A Narrative Review of ...We sought to assess the safety, feasibility, and outcomes of an at-home patient-performed surgical drain removal pilot program. Methods A ...
Prophylactic Intra-abdominal Drains in Major Elective ...Studies have demonstrated that patient-performed at-home surgical drain removal can be safe and feasible, showcasing a patient-centered approach ...
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