Clinical trial · Interventional
Negative Pressure Wound Therapy vs. Sterile Dressing for Patients Undergoing Thoracolumbar Spine Surgery
A Prospective Randomized Clinical Trial Comparing Incisional Negative Pressure Wound Therapy to Conventional Sterile Dressing in Patients Undergoing Thoracolumbar Posterior Spine Surgery
NCT03632005CI-TRIAL-00034364unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if the use of the Prevena™ System decreases the rate of subcutaneous seroma, superficial wound dehiscence and infection.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Disease | — | UNRESOLVED | — |
| Spinal Cord Injury | — | UNRESOLVED | — |
| Spinal Deformity | — | UNRESOLVED | — |
| Spinal Degeneration | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sterile dressing | Other | — | UNRESOLVED |
| Vacuum Assisted Closure | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Sterile Dressing
- description
- Standard of care treatment - Standard wound care involves the application of an occlusive dressing in the operating room, a dressing change on Post-operative Day 3 and then dressing changes as needed until suture/staple removal on Post-operative Day 14.
- interventionNames
- Other: Sterile dressing
- type
- ACTIVE_COMPARATOR
- label
- Vacuum Assisted Closure
- description
- The Prevena™ System, a type of vacuum assisted closure, is indicated for use over clean, closed incisions that continue to drain following sutured or stapled closure. It acts by removing exudate, helping hold the edges of the incision together, protecting the surgical site from external contamination in a clean, protected postoperative wound environment.
- interventionNames
- Device: Vacuum Assisted Closure
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: Patients who meet the following criteria are eligible for admission into the study: * Require spine surgery with a posterior midline incision that involves the thoracic, lumbar and/or sacral spine * Capable of and agree to consent and randomization * Be in one of the following clinical presentation groups: 1. Metastic tumor of the thoracic or lumbar spine (T1-S5), requiring instrumentation and decompression, with or without pre-operative radiation to surgical site 2. Thoracolumbar degeneration or deformity (T1-S5) with index surgery \>6 months prior, requiring revision surgery with additional instrumentation 3. Acute traumatic thoracolumbar (T1-L5) fracture(s) with neurological deficit (AIS A-C), requiring instrumentation and decompression All study participants will remain in hospital for a minimum of 7 days post-op as per standard of care. As a result, the full duration of application of the Prevena dressing will take place in hospital. Exclusion Criteria: patients who fulfill any of the following criteria are not eligible for admission into the study: * Undergoing percutaneous surgery * Active Surgical Site Infection (SSI) or primary spinal column infection or distant site infection (urinary tract, respiratory tract, etc.) at time of admission * Pregnancy The following are clinical scenarios that would mandate the patients' exclusion from final analysis: * Failure to complete the 6-week clinical follow-up (Lost to Follow Up) * Second surgery required, at the same anatomical site, during study time period (six weeks), for causes other than primary (SSI) or secondary (dehiscence, seroma) study endpoints
References
Publications (0)
Data not yet available
No reference posted for this study.