Wound Vac Bandage Comparison After Spinal Fusion

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-16

Study Completion Date

2020-07-17

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.

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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.

Conditions

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Neuromuscular Scoliosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Incisional Wound Vac

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.

Group Type ACTIVE_COMPARATOR

Incisional Wound Vac

Intervention Type DEVICE

Normal Gauze Bandage Group

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.

Group Type ACTIVE_COMPARATOR

Standard Bandage

Intervention Type OTHER

Interventions

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Incisional Wound Vac

Intervention Type DEVICE

Standard Bandage

Intervention Type OTHER

Other Intervention Names

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Incisional vacuum-assisted closure therapy Gauze Bandage Gauze

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

Minimum Eligible Age

0 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes