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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06820736

Enrollment

975

Registered

2025-02-11

Start date

2025-01-10

Completion date

2040-01-09

Last updated

2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications, Postoperative

Keywords

Lumbar spine surgery, drain, postoperative complications

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.

Detailed description

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.

Interventions

DEVICEDrain

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Reoperation	90 days postoperatively	Relative risk of return to the operating room

Secondary

Measure	Time frame	Description
Time to drain removal	90 days postoperatively	Time (minutes) to drain removal
Drain volume	90 days postoperatively	Daily volume (mL) of fluid collected by the drain
Transfusion	90 days postoperatively	Need (yes or no) for a postoperative transfusion
Length of Stay	90 days postoperatively	Length of hospital stay
Complications	90 days postoperatively	Occurrence (yes/no) of wound complications, wound dehiscence, superficial wound infection or deep wound inflection

Countries

United States

Contacts

CONTACTJohn M Dawson, PhD

RSRCH1@tcspine.com612-775-6200

CONTACTBerit A Swanberg