Wound Vac Bandage Comparison After Spinal Fusion

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of incisional vacuum-assisted closure (VAC) therapy in the prevention of infection after posterior spinal fusion for pediatric neuromuscular scoliosis, in comparison to a regular gauze bandage.

Detailed Description
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A prospective randomized controlled study: Patients undergoing posterior spinal fusion will be randomized to a standard postoperative dressing versus an incisional VAC dressing. Both groups will have hematocrit, total lymphocyte count, and albumin checked preoperatively to assess nutritional status, drawn at the same time as standard preoperative labs during history and physical visit. Both groups will undergo standard wound closure and dressing application before breaking the sterile field. The incisional VAC group will undergo placement of an Adaptic dressing over the incision. A standard VAC sponge will be placed and secured with adhesive dressing, and a suction tube will be connected to a VAC machine set to 75 mmHg of continuous suction. The incisional VAC will be left in place for 72 hours postoperatively. Remainder of postoperative care will follow our standard posterior spinal fusion protocol and will be identical in both groups. Patients will be followed for a minimum of 2 years postoperatively.

Official Title
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Incisional Vacuum-assisted Closure Therapy After Posterior Spinal Fusion for Pediatric Neuromuscular Scoliosis

Conditions
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Neuromuscular Scoliosis

Intervention / Treatment
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* Device: Incisional Wound Vac
* Other: Standard Bandage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: any patient 17 years and younger neuromuscular scoliosis undergoing posterior spinal fusion Exclusion Criteria: idiopathic and congenital scoliosis any type of spine surgery other than posterior spinal fusion (eg. vertical expandable prosthetic titanium rib placement, growing rod placement, anterior spinal fusion) intraoperative dural tear documented allergy to adhesive dressings

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Incisional Wound Vac<br>We will attach sponges and a suction tube to the incision after surgery. We will leave it on for 72 hours. From then on, patients will get the care that patients normally get after spinal fusion surgery. | Device: Incisional Wound Vac<br> <br> * Other names: Incisional vacuum-assisted closure therapy;|
| Active Comparator: Normal Gauze Bandage Group<br>We will cover patients incision with regular gauze bandages. These are the bandages that patients normally get after spinal fusion surgery. They will be left on for 72 hours. | Other: Standard Bandage<br> <br> * Other names: Gauze;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Wound Dehiscence or Infection | Participants with wound dehiscence or infection requiring unplanned dressing changes, antibiotics, or surgery | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound Vac, Neuromuscular Scoliosis, Posterior Spinal Fusion