Investigating the Feasibility and Outcomes of Patient Self-Drain Removal After Ventral Hernia Repair

Last updated: March 24, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pentalogy Of Cantrell

Hernia

Treatment

Self-drain removal

Clinical Study ID

NCT06237855
IRB00100883
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged ≥18 years.

  • Undergoing elective ventral hernia repair (VHR).

  • Sub-cutaneous drain placement.

  • Anticipated Centers for Disease Control and Preventions (CDC) 1&2 wound class.

Exclusion

Exclusion Criteria:

  • Patients who do not have access to the online training video.

  • The surgeon does not believe the patient can self-remove the drain.

  • Planned concomitant procedures.

  • Current mesh infection.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Self-drain removal
Phase:
Study Start date:
August 19, 2024
Estimated Completion Date:
January 31, 2026

Study Description

Annually, in the United States, it is estimated that 500,000 ventral hernia repairs (VHRs) are performed with a cost in excess of $3.2 billion. Drains are frequently used in an effort to prevent seroma formation. Seromas are defined as a buildup of bodily fluid in a potential space post-surgery, usually at the surgical site. Rate of seroma has been estimated to be between 9-11% following abdominal wall reconstruction (AWR). The timing of the removal is usually after discharge but before patient's scheduled postoperative visit, thus most patients must call and speak to a health provider and come in for an additional clinic visit specifically for drain removal. The goal of this study is to teach patients to safely and effectively self-remove drains at home. This will allow patients to forgo the cost associated with commuting to the clinic, the clinic cost associated with nursing time and scheduling, the clinic visit, physician or nurse time to remove the drain and possibly lost wages for the patient from time off work. It is important to note that self-drain removal will not compromise or deviate from typical patient follow up. Instead, this will eliminate an extra patient visit when inevitably the timing of drain removal does not align with the typical follow-up period. Additionally, this will allow providers to see additional patient consultations or perform other duties, as they will not have the time constraints associated with in-office drain removal. This study will show that patient self-drain removal benefits the patients, the providers, and healthcare system without compromising patient safety, satisfaction, and postoperative care.

Connect with a study center

  • Carolinas Laparoscopic & Advanced Surgery Program

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

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