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

NCT ID: NCT06237855

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-19
• Study Completion Date: 2025-06-03

Brief 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.

Detailed 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.

Conditions

Ventral Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Self-drain removal training

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 Type: EXPERIMENTAL

Self-drain removal

Intervention Type: OTHER

Subjects will be trained to self-remove drain at home following ventral hernia repair.

Interventions

Self-drain removal

Subjects will be trained to self-remove drain at home following ventral hernia repair.

Intervention Type: OTHER

Eligibility Criteria

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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Todd Heniford, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Carolinas Laparoscopic & Advanced Surgery Program

Charlotte, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00100883

Identifier Type: -

Identifier Source: org_study_id