Wound Drain After Lumbar Fusion Surgery

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Lumbar Fusion
• Intervention / Treatment: Other: Postoperative Drain Placement; Other: No Postoperative Drain Placement

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: Postoperative Drain Group; Participants will undergo their primary lumbar fusion spine surgery as planned and will have a drain placed postoperatively	Other: Postoperative Drain Placement; These drains will be placed with the intention to decrease the incidence of postoperative hematoma
Active Comparator: Group 2: No Postoperative Drain Group; Participants will undergo their primary lumbar fusion spine surgery as planned and will not have a drain placed postoperatively	Other: No Postoperative Drain Placement; Participant will undergo lumbar spine fusion surgery and will not receive a postoperative drain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative complications	Incidence of postoperative complications will be measured but recording the number of emergency department visits	1 year

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: July 31, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Estimated): August 5, 2024

Study Record Updates

• Last Update Posted (Estimated): August 5, 2024
• Last Update Submitted That Met QC Criteria: July 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023-2934CKEP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No