Wound Drain After Lumbar Fusion Surgery

Conditions

• Lumbar Fusion

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Postoperative Drain Placement — OTHER
  These drains will be placed with the intention to decrease the incidence of postoperative hematoma
• No Postoperative Drain Placement — OTHER
  Participant will undergo lumbar spine fusion surgery and will not receive a postoperative drain

Study Details

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

Key Dates

Start date

Aug 1, 2024

Status verified

Jul 2024

Primary completion

Aug 1, 2025

Completion

Aug 1, 2025

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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
• 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

Primary Outcome Measure

Incidence of postoperative complications [ Time Frame: 1 year ]

Locations (1)

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