Wound Vac Bandage Comparison After Spinal Fusion

Not Applicable

Completed

• Conditions: Neuromuscular Scoliosis
• Interventions: Device: Incisional Wound Vac; Other: Standard Bandage

• Registration Number: NCT03000010
• Lead Sponsor: University of Michigan

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-07-16
• Study First Submitted: 2016-12-18
• Study First Submitted QC: 2016-12-18
• Study First Posted: 2016-12-21
• Primary Completion: 2020-07-17
• Study Completion: 2020-07-17
• Status Verified: 2021-06
• Results First Submitted: 2021-06-05
• Results First Submitted QC: 2021-06-05
• Last Update Submitted: 2021-06-05
• Results First Posted: 2021-06-28
• Last Update Posted: 2021-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• any patient 17 years and younger
• neuromuscular scoliosis undergoing posterior spinal fusion

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Incisional Wound Vac	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.
Normal Gauze Bandage Group	Standard Bandage	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Wound Dehiscence or Infection	2 years	Participants with wound dehiscence or infection requiring unplanned dressing changes, antibiotics, or surgery

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States