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Completed

NCT Number: NCT03000010

Wound Vac Bandage Comparison After Spinal Fusion

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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Key information

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Incisional Wound Vac

Device

Other names: Incisional vacuum-assisted closure therapy

Standard Bandage

Other

Other names: Gauze Bandage, Gauze

Primary outcomes

  1. Number of Participants With Wound Dehiscence or Infection

    Time frame: 2 years

    Participants with wound dehiscence or infection requiring unplanned dressing changes, antibiotics, or surgery

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Acronym: WV

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Dec 21, 2016
Registry last updated
Jun 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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