Surgical DrainNCT07119112
Evaluation of a Novel Drain Stripping Device for Reducing Surgical Drain Complications
A study testing Surgical drain stripping device in people with Surgical Drain and Abdominal Surgery Patients, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to evaluate how well a novel surgical site drain tube clearing device works, and how easy it is for care staff to use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Drain, Abdominal Surgery Patients, Drains
- What is being tested?
- Surgical drain stripping device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult patients aged 18 years or older, with no maximum age limit.
- Patients undergoing surgical procedures that require the placement of Jackson-Pratt drains within the abdominal cavity.
- Patients who are able to provide informed consent for participation in the study.
- Mayo Clinic RNs caring for patients with post-surgical drains placed.
Who cannot join
- Patients under the age of 18.
- Patients who do not have Jackson-Pratt drains placed post-operatively.
- Patients with drains placed in locations other than the abdominal cavity.
- Patients with known allergies or contraindications to the materials used in the drain stripping device.
- Patients who are unable to provide informed consent due to cognitive impairments or any other reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this research is to evaluate how well a novel surgical site drain tube clearing device works, and how easy it is for care staff to use.
Read the detailed description
The purpose of this research is to gather information on the ease of use, effectiveness, and potential ability to reduce post-surgical drain complications of a drain stripping device which was developed and made here at the Mayo Clinic. The device has been patented and has been tested in laboratory conditions, but it has not yet been evaluated by the FDA or cleared for marketing yet since it is a device that poses minimal risk to patients. The device is a plastic clamp which is used to move fluid through the drain tubing to keep the tubing clear and free flowing. The current method (standard of care) for doing this simply involves running fingers down the tubing to drain the fluid, which can be inadequate and sometimes physically challenging. The primary goal of the study is to get feedback from nurses using the device in a clinical setting. There are approximately 80 nurses working the hospital unit which cares for patients who may have a post-surgical drain emplaced. We will gather their feedback via an anonymous survey which will be available to the nurses on the Mayo Clinic Intranet. Secondary goals of the study attempt to ascertain the potential effect of device use upon patient outcomes. Inadequate draining of surgical site fluid can sometimes create the need for additional interventions, including surgical revisions. The drain stripping device used in this study, has been developed to address these issues. Preliminary bench testing in laboratory conditions has not indicated any reason to believe that use of the device to clear surgical drain tubing poses any greater (or even different) risk to patients than the current standard of care (using bare fingers). Patients are routinely sent home with one or more surgical drains which are cleared by the patient using the current standard of care. Therefore, there is no safety related need to start with a small number of study subjects as is typical for an initial trial; and since this is not a device or drug which would be likely to show obvious benefit within a small cohort, we are seeking data regarding potential effect of study device upon patient outcomes from 420 study subject encounters (210 in each arm - device use versus current standard of care), as opposed to the small numbers of subjects usually seen in initial clinical trials.
- Conditions
- Surgical Drain, Abdominal Surgery Patients, Drains
- Being tested
- Surgical drain stripping device, Standard of Care (Investigator Choice)
- Keywords
- Surgical Drain, Drain Tube Clearance, Drain Tube Occlusion, Drain Clearance Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical drain stripping deviceDevice
We have developed a device to fully compress the surgical drain tubing without compromising the integrity of the tubing to clear the drain fluid/debris more effectively than the current standard of care.
Standard of Care (Investigator Choice)Other
Current standard of care for surgical drain tube stripping involves running fingertips down the length of the tubing compressing the drain tubing to clear fluid/debris.
| Study group | Role | What they receive |
|---|---|---|
| Drain device user(s) | Experimental | Study participants whose caregivers are utilizing the drain device to clear surgical drain tubing. Receives: Device: Surgical drain stripping device |
| Control | Other | Study participants whose caregivers use the current standard of care for surgical drain tube stripping. Receives: Other: Standard of Care (Investigator Choice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess Ease of Use and Device Functionality Via Anonymous Survey
Gather and analyze feedback from nurses regarding the ease of device use and the ability of the device to clear surgical drain tubing in the clinical setting via an anonymous survey which nurses may access within the Mayo Clinic intranet.
Measured: 1 year
Secondary outcomes (2)
Assess Effect Study Device May Have Upon Duration of Surgical Drain Placement
Compare device use and standard of care group of study subjects for the amount of time their surgical drains remain in place to assess the potential ability of the surgical drain stripping device to reduce the time needed for a surgical drain to remain in place (in situ).
Measured: 1 year
Assess Whether Device Reduces Surgical Drain Complications
Compare clinical outcomes between device use and standard of care study subjects to assess whether or not the surgical drain tube stripping device leads to fewer drain associated post operative complications.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start20 Feb 2026
- Primary completionAug 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical DrainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- We are comparing single group device user(s) to standard of care model
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rob B. Hill, Mayo Clinic
- Investigators
- Robert Hill, APRN,CNP,MSN, Principal investigator, Mayo ClinicMichael Thorn, APRN,CNP,MSN, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119112
- Sponsor's protocol ID
- 24-006697
- Status last verified
- Jan 2026
- First submitted
- 18 Jul 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The primary study goal involves collecting device use feedback via an anonymous survey, and the secondary goals involve collecting and analyzing collective data. There would be no benefit to anyone to share individual study subject data, and we would not want to consider adding a patient privacy risk factor without obvious benefit.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Drain Stripping Device for Reducing Surgical Drain Complications
- ClinicalTrials.gov ID
- NCT07119112
- Acronym / sponsor ID
- 24-006697
- Conditions
- Surgical Drain, Abdominal Surgery Patients, Drains
- Keywords
- Surgical Drain, Drain Tube Clearance, Drain Tube Occlusion, Drain Clearance Device
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 12 Aug 2025 (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 purpose of this research is to evaluate how well a novel surgical site drain tube clearing device works, and how easy it is for care staff to use.
Detailed description
The purpose of this research is to gather information on the ease of use, effectiveness, and potential ability to reduce post-surgical drain complications of a drain stripping device which was developed and made here at the Mayo Clinic. The device has been patented and has been tested in laboratory conditions, but it has not yet been evaluated by the FDA or cleared for marketing yet since it is a device that poses minimal risk to patients. The device is a plastic clamp which is used to move fluid through the drain tubing to keep the tubing clear and free flowing. The current method (standard of care) for doing this simply involves running fingers down the tubing to drain the fluid, which can be inadequate and sometimes physically challenging. The primary goal of the study is to get feedback from nurses using the device in a clinical setting. There are approximately 80 nurses working the hospital unit which cares for patients who may have a post-surgical drain emplaced. We will gather their feedback via an anonymous survey which will be available to the nurses on the Mayo Clinic Intranet. Secondary goals of the study attempt to ascertain the potential effect of device use upon patient outcomes. Inadequate draining of surgical site fluid can sometimes create the need for additional interventions, including surgical revisions. The drain stripping device used in this study, has been developed to address these issues. Preliminary bench testing in laboratory conditions has not indicated any reason to believe that use of the device to clear surgical drain tubing poses any greater (or even different) risk to patients than the current standard of care (using bare fingers). Patients are routinely sent home with one or more surgical drains which are cleared by the patient using the current standard of care. Therefore, there is no safety related need to start with a small number of study subjects as is typical for an initial trial; and since this is not a device or drug which would be likely to show obvious benefit within a small cohort, we are seeking data regarding potential effect of study device upon patient outcomes from 420 study subject encounters (210 in each arm - device use versus current standard of care), as opposed to the small numbers of subjects usually seen in initial clinical trials.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We are comparing single group device user(s) to standard of care model
| Arm | Type | Receives |
|---|---|---|
| Drain device user(s) | Experimental | Device: Surgical drain stripping deviceStudy participants whose caregivers are utilizing the drain device to clear surgical drain tubing. |
| Control | Other | Other: Standard of Care (Investigator Choice)Study participants whose caregivers use the current standard of care for surgical drain tube stripping. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged 18 years or older, with no maximum age limit.
- Patients undergoing surgical procedures that require the placement of Jackson-Pratt drains within the abdominal cavity.
- Patients who are able to provide informed consent for participation in the study.
- Mayo Clinic RNs caring for patients with post-surgical drains placed.
Key exclusion criteria (5 listed)
- Patients under the age of 18.
- Patients who do not have Jackson-Pratt drains placed post-operatively.
- Patients with drains placed in locations other than the abdominal cavity.
- Patients with known allergies or contraindications to the materials used in the drain stripping device.
- Patients who are unable to provide informed consent due to cognitive impairments or any other reason.
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 |
|---|---|---|
| Surgical drain stripping deviceWe have developed a device to fully compress the surgical drain tubing without compromising the integrity of the tubing to clear the drain fluid/debris more effectively than the current standard of care. | Device | Drain device user(s) |
| Standard of Care (Investigator Choice)Current standard of care for surgical drain tube stripping involves running fingertips down the length of the tubing compressing the drain tubing to clear fluid/debris. | Other | Control |
Primary outcome
Assess Ease of Use and Device Functionality Via Anonymous Survey
Time frame: 1 year
Gather and analyze feedback from nurses regarding the ease of device use and the ability of the device to clear surgical drain tubing in the clinical setting via an anonymous survey which nurses may access within the Mayo Clinic intranet.
2 secondary outcomes
Assess Effect Study Device May Have Upon Duration of Surgical Drain Placement
Time frame: 1 year
Assess Whether Device Reduces Surgical Drain Complications
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No. The primary study goal involves collecting device use feedback via an anonymous survey, and the secondary goals involve collecting and analyzing collective data. There would be no benefit to anyone to share individual study subject data, and we would not want to consider adding a patient privacy risk factor without obvious benefit.
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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.
Robert Hill, APRN,CNP,MSN principal investigator
Mayo Clinic
Michael Thorn, APRN,CNP,MSN principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical drain stripping device in people with Surgical Drain and Abdominal Surgery Patients, run by Mayo Clinic 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 5 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: enrolling by invitation, as of the sponsor's last update on 24 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Assess Ease of Use and Device Functionality Via Anonymous Survey (time frame: 1 year). 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 24 Feb 2026.