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OpenTrials
Enrolling by Invitation

NCT Number: NCT06536842

Wound Drain After Lumbar Fusion Surgery

Postoperative drain placement is often used following spine surgery. These drains are placed with the intention to decrease the incidence of postoperative hematoma and its associated complications including wound complications, infections and neurologic compression.

The use of drains, however, are not without its disadvantages including the risk of retrograde infection, increased postoperative blood loss, increased length of stay and increased hospital costs. The purpose of this study is to evaluate the postoperative outcomes and complications in patients undergoing primary lumbar fusion with and without a postoperative drain

Enrolling by Invitation

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Key information

Conditions

Lumbar Fusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age > 18
  • Undergoing primary lumbar fusion or decompression and fusion for 1-2 levels
  • Surgery indicated for lumbar degenerative disease

Exclusion criteria

  • Undergoing revision surgery
  • Surgery indicated for infection
  • Intraoperative dural tear
  • Surgery requiring intraoperative transfusion

Treatment and study plan

Postoperative Drain Placement

Other

These drains will be placed with the intention to decrease the incidence of postoperative hematoma

No Postoperative Drain Placement

Other

Participant will undergo lumbar spine fusion surgery and will not receive a postoperative drain

Primary outcomes

  1. Incidence of postoperative complications

    Time frame: 1 year

    Incidence of postoperative complications will be measured but recording the number of emergency department visits

Sponsors and collaborators

Lead sponsor

Rothman Institute Orthopaedics

Other

Registry information

Official study title

Postoperative Outcomes Following Primary Lumbar Fusion in Patients With and Without a Drain: A Prospective Randomized Control Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2024
Registry last updated
Aug 5, 2024

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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