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NCT Number: NCT06820736

A Prospective, Randomized Comparison Of Drainage Techniques After One- Or Two-Level Open Posterior Lumbar Decompression Or Decompression And Fusion

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

Recruiting

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Key information

Conditions

Complications, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The primary objective is to prospectively evaluate drains used in lumbar spine surgery in patients undergoing one- or two-level open posterior lumbar decompression or decompression and fusion for the relative risk of return to the operating room within 90 days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drain

Device

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

Primary outcomes

  1. Reoperation

    Time frame: 90 days postoperatively

    Relative risk of return to the operating room

Secondary outcomes

  1. Time to drain removal

    Time frame: 90 days postoperatively

    Time (minutes) to drain removal

  2. Drain volume

    Time frame: 90 days postoperatively

    Daily volume (mL) of fluid collected by the drain

  3. Transfusion

    Time frame: 90 days postoperatively

    Need (yes or no) for a postoperative transfusion

  4. Length of Stay

    Time frame: 90 days postoperatively

    Length of hospital stay

  5. Complications

    Time frame: 90 days postoperatively

    Occurrence (yes/no) of wound complications, wound dehiscence, superficial wound infection or deep wound inflection

Study contacts

Contact information is provided by the study sponsor or research team.

Berit A Swanberg

CONTACT

[email protected]

612-775-6200

John M Dawson, PhD

CONTACT

[email protected]

612-775-6200

Sponsors and collaborators

Lead sponsor

Twin Cities Spine Center

Other

Collaborators

  • Allina Health System

Registry information

Important dates

Study start
2025
Primary completion
2035
Study completion
2040
First posted
Feb 11, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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