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

Ventral Hernia Clinical Trial

— SDR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06237855
• Other study ID #: IRB00100883
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: Greg Scarola, MS
• Phone: 704-355-5379
• Email: Gregory.Scarola[@]AtriumHealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

Other:
• Self-drain removal
Subjects will be trained to self-remove drain at home following ventral hernia repair.

Locations

Country	Name	City	State
United States	Carolinas Laparoscopic & Advanced Surgery Program	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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
Secondary	Difference In Subject Costs	Difference in cost associated with reduction in clinic visits.	30-days post-operatively
Secondary	Difference in Subject Amount of Time	Difference in time associated with reduction in clinic visits and travel	30-days post-operatively