Wound Drain After Lumbar Fusion Surgery

Not Applicable

• Conditions: Lumbar Fusion
• Interventions: Other: Postoperative Drain Placement; Other: No Postoperative Drain Placement

• Registration Number: NCT06536842
• Lead Sponsor: Rothman Institute Orthopaedics

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-31
• Study First Submitted QC: 2024-07-31
• Last Update Submitted: 2024-07-31
• Study Start: 2024-08-01
• Study First Posted: 2024-08-05
• Last Update Posted: 2024-08-05
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Postoperative Drain Group	Postoperative Drain Placement	Participants will undergo their primary lumbar fusion spine surgery as planned and will have a drain placed postoperatively
Group 2: No Postoperative Drain Group	No Postoperative Drain Placement	Participants will undergo their primary lumbar fusion spine surgery as planned and will not have a drain placed postoperatively

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative complications	1 year	Incidence of postoperative complications will be measured but recording the number of emergency department visits

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States