Ventral Hernia
Conditions
Keywords
hernia repairs, drain removal, subcutaneous drains
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.
Interventions
OTHERSelf-drain removal
Subjects will be trained to self-remove drain at home following ventral hernia repair.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Comparison of control group (drain removal in clinic via provider) versus intervention group self-removing drain at home.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of patients self-removing drains | 2 weeks post-operatively | Percentage of patients that are able to safely self-remove drain at home. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound complication rate | 30-days post-operatively. | 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. |
| Change in drain removal training survey scores from pre to post training | Hour 1 | 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. |
| Post-drain removal satisfaction survey scores | 30-days post-operatively | 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. |
| Difference In Subject Costs | 30-days post-operatively | Difference in cost associated with reduction in clinic visits. |
| Difference in Subject Amount of Time | 30-days post-operatively | Difference in time associated with reduction in clinic visits and travel |
Countries
United States
Outcome results
None listed