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

NCT06237855 | Terminated

• 1 other identifier: IRB00100883
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventral Hernia

Keywords

hernia repairs; drain removal; subcutaneous drains

Outcome Measures

Primary Outcomes (1)

• Success rate of patients self-removing drains

  Percentage of patients that are able to safely self-remove drain at home.

  2 weeks post-operatively

Secondary Outcomes (5)

• Wound complication rate

  30-days post-operatively.

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

  Hour 1

• Post-drain removal satisfaction survey scores

  30-days post-operatively

• Difference In Subject Costs

  30-days post-operatively

• Difference in Subject Amount of Time

  30-days post-operatively

Study Arms (2)

Standard of Care

NO INTERVENTION

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

Self-drain removal training

EXPERIMENTAL

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

Other: Self-drain removal

Interventions

Self-drain removal OTHER

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

Self-drain removal training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Carolinas Laparoscopic & Advanced Surgery Program

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Todd Heniford, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison of control group (drain removal in clinic via provider) versus intervention group self-removing drain at home.

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 2, 2024
• Study Start: August 19, 2024
• Primary Completion: June 3, 2025
• Study Completion: June 3, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)