Incisional Negative Pressure Wound Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Efficacy of Negative Pressure Wound Therapy (NPWT) in the Postoperative Management of Complex Spinal Surgeries: A Randomized Outcomes Study.

Conditions
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Spinal Deformity

Intervention / Treatment
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* Device: Negative pressure wound therapy (NPWT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Negative Pressure Wound Therapy Device<br>This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine. | |
| Experimental: NPWT Arm Therapy<br>This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery. | Device: Negative pressure wound therapy (NPWT)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Post-operative Infection (NPWT) | The patient will be assessed for signs/symptoms of infection within the 3 month post-operative period. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Deformity, Complex Spinal Surgery, Negative Pressure Wound Therapy, Post-Operative Infection