NCT03000010

Wound Vac Bandage Comparison After Spinal Fusion

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 0 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Neuromuscular Scoliosis

Interventions

Type	Name	Description
DEVICE	Incisional Wound Vac
OTHER	Standard Bandage

Timeline

• Start date: 2012-07-16
• Primary completion: 2020-07-17
• Completion: 2020-07-17
• First posted: 2016-12-21
• Last updated: 2021-06-28
• Results posted: 2021-06-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study