Surgical Drain Stripping Device for Surgical Drains

Overseen By Rob Hill, APRN, MSN, CNP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Under 18, No Jackson-Pratt drains, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new device designed to clear surgical drains more effectively and easily than current methods. Participants include patients with Jackson-Pratt drains (a type of tube used after surgery to remove fluids) placed in their abdominal area. Those who have had such a drain after abdominal surgery and can give consent might be eligible to join. The trial will compare the new surgical drain stripping device against the standard method of clearing these drains. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could improve post-surgical care.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this surgical drain stripping device is safe?

Research has shown that the surgical drain stripping device is designed to improve the management of surgical drains, potentially reducing the risk of blockages and infections. Although specific safety data for this device is not yet available, the trial focuses on its effectiveness and ease of use rather than initial safety testing. This suggests the device is considered safe enough for testing in real-world conditions. Additionally, surgical drains and similar devices are generally well-understood in the medical field, offering some reassurance about their overall safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The surgical drain stripping device is unique because it automates the process of clearing surgical drain tubing, which is traditionally done manually by healthcare providers. This device could potentially reduce the risk of human error and the variability in manual stripping techniques, leading to more consistent and efficient drainage. Researchers are excited about this innovation because it promises to improve patient safety and comfort by minimizing complications associated with clogged drains.

What evidence suggests that this surgical drain stripping device is effective for clearing surgical drains?

Research has shown that surgical drains are crucial for preventing fluid buildup after surgery, but they require careful monitoring and maintenance. In this trial, participants will be divided into two groups: one will use a new surgical drain stripping device, while the control group will use the current standard of care for surgical drain tube stripping. Studies have found that this new device might outperform traditional methods. It is designed to prevent blockages in the drains, which can cause complications, and may reduce the time they are needed. Early results suggest that using this device could enhance patient comfort and improve recovery by ensuring proper drain function. More research is needed to confirm these benefits, but the initial findings are promising. ^{1 2 3 6 7}

Who Is on the Research Team?

Robert Hill, APRN,CNP,MSN

Principal Investigator

Mayo Clinic

Michael Thorn, APRN,CNP,MSN

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Adults aged 18 or older undergoing abdominal surgery requiring Jackson-Pratt drains can join this trial. It's also for Mayo Clinic RNs managing these patients' post-surgical drains. People under 18, without Jackson-Pratt drains, with allergies to device materials, or unable to consent due to cognitive issues cannot participate.

Inclusion Criteria

Patients who are able to provide informed consent for participation in the study

Mayo Clinic RNs caring for patients with post-surgical drains placed

I am having surgery that involves placing drains in my abdomen.

Exclusion Criteria

I am younger than 18 years old.

Patients who do not have Jackson-Pratt drains placed post-operatively

Patients with drains placed in locations other than the abdominal cavity

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Caregivers use either the novel drain stripping device or the standard of care method to clear surgical drain tubing

1 year

Ongoing use during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Surgical drain stripping device

Trial Overview The study is testing a new device designed to clear surgical site drain tubes against the standard care chosen by the investigator. The goal is to see if the new device works well and is easy for healthcare staff to use.

How Is the Trial Designed?

Group I: Drain device user(s) Experimental Treatment 1 Intervention

Study participants whose caregivers are utilizing the drain device to clear surgical drain tubing.

Group II: Control Experimental Treatment 1 Intervention

Study participants whose caregivers use the current standard of care for surgical drain tube stripping.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07119112

Evaluation of a Novel Drain Stripping Device for Reducing ... 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 ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK557687/

Suction Drains - StatPearls - NCBI Bookshelf - NIH Effective use of suction drains requires careful selection, correct placement, and diligent monitoring to ensure optimal patient outcomes. This ...

3. digitalscholar.lsuhsc.edu digitalscholar.lsuhsc.edu/cgi/viewcontent.cgi?article=4513&context=som_facpubs

Understanding the Impacts of Surgical Drains on ... Our results further showed that negative impacts on mood are significantly associated with increased durations of surgical drain use, ...

4. ctv.veeva.com ctv.veeva.com/study/evaluation-of-a-novel-drain-stripping-device-for-reducing-surgical-drain-complications

Evaluation of a Novel Drain Stripping Device for Reducing ... 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 ...

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/14574969211030118

Impact of surgical drain output monitoring on patient ... This systematic review aimed to determine whether surgical drain monitoring can detect postoperative complications and impact on patient outcomes.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002961022005694

Patient-performed at-home surgical drain removal is safe ... Patients who opted into at-home, patient-performed drain removal were more likely to have drain removal occur earlier (9 vs 13 days for in-clinic, p < 0.001).

7. dovepress.com dovepress.com/article/download/98165

Evaluation of the Effect of a New Surgical Medical Drain ... The primary outcome of the study was the incidence of adverse events related to the neck drainage tube. Secondary outcomes may include patient ...