Wound Drain After Lumbar Fusion Surgery

Rothman Institute Orthopaedics

Status: Invitation-only

Conditions: Lumbar Fusion

Treatments: Other: Postoperative Drain Placement; Other: No Postoperative Drain Placement

Study type: Interventional

Funder types: Other

Identifiers

NCT06536842

2023-2934CKEP

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Group 1: Postoperative Drain Group

Active Comparator group

Description:

Participants will undergo their primary lumbar fusion spine surgery as planned and will have a drain placed postoperatively

Treatment:

Other: Postoperative Drain Placement

Group 2: No Postoperative Drain Group

Active Comparator group

Description:

Participants will undergo their primary lumbar fusion spine surgery as planned and will not have a drain placed postoperatively

Treatment:

Other: No Postoperative Drain Placement