Self-Drain Removal for Hernia

(SDR Trial)

Overseen By Greg Scarola, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: No video access, Mesh infection, others

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

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

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. ^{1 2 3 4 5}

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. ^{1 2 3 5 6}

Who Is on the Research Team?

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

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?

Group I: Self-drain removal training Experimental Treatment 1 Intervention

Subjects will remove drain at home Training will consist of a detailed online video of a provider instructing how to remove the drain and practicing on a model created specifically to mimic the following actions during drain self-removal: * Tension required to remove the drain * Placing and taping gauze after suture and drain removal

Group II: Standard of Care Active Control 1 Intervention

Drain removal will occur during clinic visit by provider per standard of care procedure.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Slit drainage--progress in drainage treatment after herniotomy]. Graupe, F., Böhm, B., Hucke, HP., et al.[2006]

A systematic review found only one eligible trial involving 24 patients comparing two types of drains (electrified vs. corrugated) after incisional hernia repair, showing no significant differences in wound infection rates or hospital stay length.

Overall, there is insufficient evidence to conclude whether using wound drains during incisional hernia repair leads to better or worse patient outcomes compared to not using drains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wound drains after incisional hernia repair. Gurusamy, KS., Allen, VB., Samraj, K.[2020]

A randomized controlled trial found no significant difference in major postoperative complications or recurrence rates between patients discharged 48 hours versus those discharged 6-7 days after inguinal hernia and varicose vein surgeries.

Early discharge (48 hours) resulted in cost savings of approximately £25.72 per patient, although families of short-stay patients were less supportive of this approach compared to families of long-stay patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of early discharge for inguinal hernia and varicose veins. Adler, MW., Waller, JJ., Creese, A., et al.[2020]

In a study of 100 patients who underwent total hip arthroplasty (THA), the average daily steps recorded during hospitalization were 1528, indicating a level of post-operative mobility that can be tracked effectively using Fitbit® activity trackers.

The study found that 65% of patients were open to using new technologies like activity trackers for rehabilitation, suggesting that integrating such devices could enhance patient engagement and motivation in post-operative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postoperative mobilization after total hip arthroplasty : Measured by Fitbit activity trackers]. Doppelbauer, M., Schüler, M., Sauter, D.[2020]

In a study of 756 day surgery patients, those with lower preoperative mental health scores experienced significantly poorer recovery outcomes, indicating the importance of mental health in postoperative recovery.

Similarly, patients with lower preoperative physical health scores also showed worse recovery, suggesting that both mental and physical health assessments should be integral to preoperative evaluations for better recovery planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low Preoperative Mental and Physical Health is Associated with Poorer Postoperative Recovery in Patients Undergoing Day Surgery: A Secondary Analysis from a Randomized Controlled Study. Nilsson, U., Dahlberg, K., Jaensson, M.[2023]

The study involved 14 patients with incisional hernias, including 13 with hernias at the main laparotomy wound and one with an isolated drain-site hernia, all treated with laparoscopic meshplasty and suturing.

Laparoscopic repair of incisional hernias is effective and cost-efficient, allowing for simultaneous repair of multiple hernia sites without the need for expensive tacking devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic management of drain-site incisional hernias following laparotomies--a simple suture technique. Palanivelu, C., Rangarajan, M., Senthilkumar, R., et al.[2007]

Establishing a dedicated hernia clinic significantly improved surgical outcomes for external abdominal wall herniorrhaphy, with lower rates of recurrence, infection, and testicular ischemia compared to previous institutional results.

Patients over 65 years of age also experienced a notable decrease in incarceration/strangulation incidents, highlighting the clinic's effectiveness in managing hernia complications in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hernia clinic in a teaching institution: creation and development. Deysine, M.[2019]

The introduction of same-day herniorrhaphy by Medicare and other insurers has led to a shift towards outpatient surgical centers for hernia repairs, emphasizing the need for high-quality care in this new setting.

The tension-free repair technique using modern mesh prosthetics significantly reduces the risk of hernia recurrence by eliminating suture line tension, resulting in a simpler, faster, and less painful recovery for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory outpatient hernia surgery. Including a new concept, introducing tension-free repair. Lichtenstein, IL., Shulman, AG.[2011]

Citations

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pubmed.ncbi.nlm.nih.gov

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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.

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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 ...

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cureus.com

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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.

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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).

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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 ...

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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 ...