Clinical trial NCT06237855: Investigating the Feasibility and Outcomes of Patient Self-Drain Removal After Ventral Hernia Repair
Official title: Empowering Patients: A Randomized Controlled Trial (RCT) Investigating the Feasibility and Outcomes of Patient Self-Drain Removal After Ventral Hernia Repair
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ventral Hernia
Keywords: hernia repairs
drain removal
subcutaneous drains
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of control group (drain removal in clinic via provider) versus intervention group self-removing drain at home.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Success rate of patients self-removing drains
timeFrame: 2 weeks post-operatively
Secondary outcomes:
measure: Wound complication rate
timeFrame: 30-days post-operatively.
measure: Change in drain removal training survey scores from pre to post training
timeFrame: Hour 1
measure: Post-drain removal satisfaction survey scores
timeFrame: 30-days post-operatively
measure: Difference In Subject Costs
timeFrame: 30-days post-operatively
measure: Difference in Subject Amount of Time
timeFrame: 30-days post-operatively
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Laparoscopic & Advanced Surgery Program
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Todd Heniford, MD
role: PRINCIPAL_INVESTIGATOR
References: