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

Empowering Patients: A Randomized Controlled Trial (RCT) Investigating the Feasibility and Outcomes of Patient Self-Drain Removal After Ventral Hernia Repair

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ventral Hernia
• Intervention / Treatment: Other: Self-drain removal

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Greg Scarola, MS; Phone Number: 704-355-5379; Email: Gregory.Scarola@AtriumHealth.org
• Study Contact Backup: Name: Todd Heniford, MD; Phone Number: 704-355-2000; Email: Todd.Heniford@AtriumHealth.org

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Laparoscopic & Advanced Surgery Program
      • Principal Investigator: Todd Heniford, MD
      • Contact: Gregory Scarola, MS; Phone Number: 704-355-5766; Email: Gregory.Scarola@atriumhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; Drain removal will occur during clinic visit by provider per standard of care procedure.
Experimental: 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	Other: Self-drain removal; Subjects will be trained to self-remove drain at home following ventral hernia repair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound complication rate	Comparison of the wound complication rate between the control and intervention groups. Wound complications will be defined as wound breakdown, wound cellulitis, hematoma, wound infection, and seroma requiring intervention. Each wound complication will be reported individually and as an aggregate wound complication overall rate.	30-days post-operatively.
Change in drain removal training survey scores from pre to post training	Change in drain removal training survey scores from pre to post training. The same survey is given pre and post is training and is on a 5-point Likert scale survey with 1 representing "strongly disagree" and 5 representing "strongly agree". Higher scores indicate more confidence in the self-drain removing process.	Hour 1
Post-drain removal satisfaction survey scores	Score on satisfaction survey following self-drain removal (intervention group only). Survey is on a 5-point Likert scale survey with 1 representing "strongly disagree" and 5 representing "strongly agree". Higher scores indicate greater satisfaction with at home self-drain removal.	30-days post-operatively
Difference In Subject Costs	Difference in cost associated with reduction in clinic visits.	30-days post-operatively
Difference in Subject Amount of Time	Difference in time associated with reduction in clinic visits and travel	30-days post-operatively

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Todd Heniford, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: January 15, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: drain removal; hernia repairs; subcutaneous drains
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: IRB00100883

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No