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

NCT07119112 | Enrolling By Invitation

• 1 other identifier: 24-006697
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgical Drain; Abdominal Surgery Patients; Drains

Keywords

Surgical Drain; Drain Tube Clearance; Drain Tube Occlusion; Drain Clearance Device

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (2)

• Assess Effect Study Device May Have Upon Duration of Surgical Drain Placement

  1 year

• Assess Whether Device Reduces Surgical Drain Complications

  1 year

Study Arms (2)

Drain device user(s)

EXPERIMENTAL

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

Device: Surgical drain stripping device

Control

OTHER

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

Other: Standard of Care (Investigator Choice)

Interventions

Surgical drain stripping device DEVICE

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.

Drain device user(s)

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Robert Hill, APRN,CNP,MSN

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Michael Thorn, APRN,CNP,MSN

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: We are comparing single group device user(s) to standard of care model

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: August 12, 2025
• Study Start: February 20, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)