Self-Drain Removal for Hernia

(SDR Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Todd Heniford, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Wake Forest University Health Sciences

Disqualifiers: No video access, Mesh infection, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this randomized controlled trial is to teach patients to safely and effectively self-remove drains at home in adults (aged 18 and older) following a ventral hernia repair (VHR). Researchers will compare the group of subjects self-removing the drain at home to a control group of standard of care drain removal during a clinic visit by a provider to see if subjects are able to safely self-remove the drain at home.

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 Self-drain removal for hernia?

The research on outpatient hernia surgery and early discharge suggests that patients can effectively manage their recovery at home, which supports the idea of self-drain removal being feasible and safe. Additionally, the study on early discharge for hernia patients found no significant difference in complications, indicating that patients can handle post-operative care, including self-drain removal, without increased risk. ^{1 2 3 4 5}

How does self-drain removal for hernia differ from other treatments?

Self-drain removal for hernia is unique because it allows patients to remove their own surgical drains at home, potentially reducing the need for follow-up visits to the doctor. This contrasts with traditional methods where medical professionals typically handle drain removal, which can be more painful and require more force, as seen with Redon-suction drains. ^{6 7 8 9 10}

Research Team

Todd Heniford, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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 18 years old or older.

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

Trial Timeline

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

Treatment Details

Interventions

• Self-drain removal (Procedure)

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.

Participant Groups

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+

Dr. L. Ebony Boulware

Wake Forest University Health Sciences

Chief Medical Officer since 2022

MD from Duke University School of Medicine, MPH from Johns Hopkins Bloomberg School of Public Health

Dr. Julie Ann Freischlag

Wake Forest University Health Sciences

Chief Executive Officer since 2020

BS from University of Illinois, MD from Rush University

Findings from Research

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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

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

2. United States 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. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

[Postoperative mobilization after total hip arthroplasty : Measured by Fitbit activity trackers]. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of early discharge for inguinal hernia and varicose veins. [2020]

5. France pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

[Short-term drainage in inguinal hernia repair]. [2007]

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

Laparoscopic management of drain-site incisional hernias following laparotomies--a simple suture technique. [2007]

8. England pubmed.ncbi.nlm.nih.gov

Wound drains after incisional hernia repair. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

[Removal of a fixed T-drain following detachment by a ring stripper]. [2006]

10. Germany pubmed.ncbi.nlm.nih.gov

[Slit drainage--progress in drainage treatment after herniotomy]. [2006]