Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06237855
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-01-15
Brief Title:
Investigating the Feasibility and Outcomes of Patient Self-Drain Removal After Ventral Hernia Repair
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Empowering Patients A Randomized Controlled Trial RCT Investigating the Feasibility and Outcomes of Patient Self-Drain Removal After Ventral Hernia Repair
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SDR
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 500000 ventral hernia repairs VHRs are performed with a cost in excess of 32 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None