Evaluation of a Novel Drain Stripping Device for Reducing Surgical Drain Complications

Mayo Clinic

Status: Not yet enrolling

Conditions: Drains; Abdominal Surgery Patients; Surgical Drain

Treatments: Other: Standard of Care (Investigator Choice); Device: Surgical drain stripping device

Study type: Interventional

Funder types: Other

Identifiers

NCT07119112

24-006697

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Drain device user(s)

Experimental group

Description:

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

Treatment:

Device: Surgical drain stripping device

Control

Other group

Description:

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

Treatment:

Other: Standard of Care (Investigator Choice)