Wound Drain After Lumbar Fusion Surgery

NCT06536842 | Enrolling By Invitation

• 1 other identifier: 2023-2934CKEP
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Lumbar Fusion

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative complications

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

  1 year

Study Arms (2)

Group 1: Postoperative Drain Group

ACTIVE COMPARATOR

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

Other: Postoperative Drain Placement

Group 2: No Postoperative Drain Group

ACTIVE COMPARATOR

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

Other: No Postoperative Drain Placement

Interventions

Postoperative Drain Placement OTHER

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

Group 1: Postoperative Drain Group

No Postoperative Drain Placement OTHER

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

Group 2: No Postoperative Drain Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 5, 2024

Record last verified: 2024-07

Locations

US (1)