Ventral HerniaSDRNCT06237855
Investigating the Feasibility and Outcomes of Patient Self-Drain Removal After Ventral Hernia Repair
A study testing Self-drain removal in people with Ventral Hernia, run by Wake Forest University Health Sciences at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Self-drain removal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2024to 3 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Laparoscopic & Advanced Surgery Program
Charlotte, North Carolina, 28204
About this study
Official title: 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.
Read the 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.
- Conditions
- Ventral Hernia
- Being tested
- Self-drain removal
- Keywords
- hernia repairs, drain removal, subcutaneous drains
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-drain removalOther
Subjects will be trained to self-remove drain at home following ventral hernia repair.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Drain removal will occur during clinic visit by provider per standard of care procedure. |
| Self-drain removal training | Experimental | 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 Receives: Other: Self-drain removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of patients self-removing drains
Percentage of patients that are able to safely self-remove drain at home.
Measured: 2 weeks post-operatively
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 30-days post-operatively
Difference In Subject Costs
Difference in cost associated with reduction in clinic visits.
Measured: 30-days post-operatively
Difference in Subject Amount of Time
Difference in time associated with reduction in clinic visits and travel
Measured: 30-days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start19 Aug 2024
- Primary completion3 Jun 2025
- Study completion3 Jun 2025
Why it stopped: Principal investigator left the institution and no other investigator wants to continue the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of control group (drain removal in clinic via provider) versus intervention group self-removing drain at home.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Todd Heniford, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237855
- Sponsor's protocol ID
- IRB00100883
- Acronym
- SDR
- Status last verified
- Mar 2025
- First submitted
- 15 Jan 2024
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Patients: A Randomized Controlled Trial (RCT) Investigating the Feasibility and Outcomes of Patient Self-Drain Removal After Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT06237855
- Acronym / sponsor ID
- SDR / IRB00100883
- Conditions
- Ventral Hernia
- Keywords
- hernia repairs, drain removal, subcutaneous drains
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal investigator left the institution and no other investigator wants to continue the study.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison of control group (drain removal in clinic via provider) versus intervention group self-removing drain at home.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Drain removal will occur during clinic visit by provider per standard of care procedure. |
| Self-drain removal training | Experimental | Other: Self-drain removalSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-drain removalSubjects will be trained to self-remove drain at home following ventral hernia repair. | Other | Self-drain removal training |
Primary outcome
Success rate of patients self-removing drains
Time frame: 2 weeks post-operatively
Percentage of patients that are able to safely self-remove drain at home.
5 secondary outcomes
Wound complication rate
Time frame: 30-days post-operatively.
Change in drain removal training survey scores from pre to post training
Time frame: Hour 1
Post-drain removal satisfaction survey scores
Time frame: 30-days post-operatively
Difference In Subject Costs
Time frame: 30-days post-operatively
Difference in Subject Amount of Time
Time frame: 30-days post-operatively
Results and safety
The study was stopped early (reason given: Principal investigator left the institution and no other investigator wants to continue the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Heniford, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-drain removal in people with Ventral Hernia, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal investigator left the institution and no other investigator wants to continue the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of patients self-removing drains (time frame: 2 weeks post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.