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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 belowSelect...
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
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 moreAwards & 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.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,403 Previous Clinical Trials
2,477,835 Total Patients Enrolled
Todd Heniford, MDPrincipal InvestigatorWake Forest University Health Sciences
5 Previous Clinical Trials
1,008 Total Patients Enrolled