The Efficacy of Negative Pressure Wound Therapy (NPWT) in the Postoperative Management of Complex Spinal Surgeries: A Randomized Outcomes Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 19
- Locations
- 2
- Primary Endpoint
- Number of Participants With Post-operative Infection (NPWT)
Study Overview
Brief Summary
The purpose of this study is to evaluate the outcome of incisional negative pressure wound therapy in preventing surgical site infections and wound complications (dehiscence) in high-risk patients undergoing complex spinal surgery.
Detailed Description
This randomized, controlled study will compare the outcomes of NPWT versus the outcomes of not using NPWT in post-operative wound management following a complex spinal surgery. The allocation of patients (no NPWT device versus applying an NPWT device) will be determined by computer-generated randomization. The following data will be collected to determine impact on the outcome of wound management (i.e., infection and wound dehiscence): age, gender, body mass index (BMI), dorsal fat, estimated blood loss during the surgical procedure, length of surgery, length of hospital stay, highest peri-operative glucose, medical comorbidities, and history of infection.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •>/= 18 years of age
- •>/= 3 level instrumented thoracic, lumbar, or thoracolumbar spinal fusion
Exclusion Criteria
- •< 18 years of age
- •< 3 level instrumented thoracic, lumbar, or thoracolumbar spinal fusion
- •Spinal infection at time of surgery
- •History of immunosuppression or chronic systemic infection
- •Pregnancy
- •Inability to provide informed consent
Outcomes
Primary Outcomes
Number of Participants With Post-operative Infection (NPWT)
Time Frame: 3 months
The patient will be assessed for signs/symptoms of infection within the 3 month post-operative period.
Secondary Outcomes
No secondary outcomes reported