Recruiting

Drainage Techniques

Sponsor:

Twin Cities Spine Center

Code:

NCT06820736

Conditions

Complications, Postoperative

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Drain

Study Details

Brief summary:

This project is being done to understand if a drain reduces recovery problems after surgery, such as infection or the need for more surgery.

Conditions

Complications, Postoperative

Study ID

NCT06820736

Start date

Jan 10, 2025

Status verified date

Jun, 2026

Completion date

Jan 9, 2040

Anticipated

Primary completion date

Jan 9, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • One or two-level open spinal decompression or decompression and fusion for the treatment of lumbar stenosis and/or spondylolisthesis

Exclusion Criteria:

  • Infection, tumor, or trauma
  • Prior lumbar fusion surgery
  • Lumbar fusion surgery at more than 2 levels
  • Anterior lumbar surgery
  • Perioperative anticoagulation treatment
  • Intraoperative incidental durotomy
  • Intraoperative or postoperative cerebrospinal fluid leakage
  • Intraoperative EBL greater than one liter

Study Design

Enrollment

975 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active Drain

The drain will be used with compression suction.

experimental: Passive Drain

The drain will be used with gravity alone.

no intervention: No Drain

No drain will be used.

Interventions

Drain

A drain is a small flexible tube that is placed next to where the spine was operated upon.

Primary outcome measure

  • Reoperation [ Time Frame: 90 days postoperatively ]

Central Contacts and Locations

Central contacts

John M Dawson, PhD

612-775-6200RSRCH1@tcspine.com

Berit A Swanberg

612-775-6200RSRCH1@tcspine.com

Locations

Abbott Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

John M Dawson, PhD

612-775-6200RSRCH1@tcspine.com

Berit A Swanberg

612-775-6200RSRCH1@tcspine.com

Principal Investigator:

Ben Mueller, MD, PhD

More Information

Sponsor

Twin Cities Spine Center

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Keywords

  • Lumbar spine surgery
  • drain
  • postoperative complications

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Twin Cities Spine Center on 2026-07-02.