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Self-Drain Removal for Hernia (SDR Trial)

N/A

Recruiting

Led By Todd Heniford, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Sub-cutaneous drain placement

Aged ≥18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30-days post-operatively

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if patients who have had a ventral hernia repair surgery can safely remove their drains at home instead of having it removed by a healthcare provider during a clinic visit. Researchers will

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed, potential issues could include discomfort during removal, infection risk at the drain site, or improper removal leading to complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a drain placed under my skin.

Select...

I am 18 years old or older.

Select...

I am scheduled for elective surgery to repair a ventral hernia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30-days post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30-days post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30-days post-operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Success rate of patients self-removing drains

Secondary study objectives

Change in drain removal training survey scores from pre to post training

Difference In Subject Costs

Difference in Subject Amount of Time

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Self-drain removal trainingExperimental Treatment1 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 CareActive Control1 Intervention

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

0 / 3Eligibility criteria met