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Wound Drain After Lumbar Fusion Surgery

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06536842
Enrollment
200
Registered
2024-08-05
Start date
2024-08-01
Completion date
2025-08-01
Last updated
2024-08-05

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

Conditions

Lumbar Fusion

Brief summary

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

Interventions

OTHERPostoperative Drain Placement

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

OTHERNo Postoperative Drain Placement

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

Sponsors

Rothman Institute Orthopaedics
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of postoperative complications1 yearIncidence of postoperative complications will be measured but recording the number of emergency department visits

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026