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Wound Vac Bandage Comparison After Spinal Fusion (WV)

Primary Purpose

Neuromuscular Scoliosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Incisional Wound Vac
Standard Bandage
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuromuscular Scoliosis focused on measuring Wound Vac, Neuromuscular Scoliosis, Posterior Spinal Fusion

Eligibility Criteria

0 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Incisional Wound Vac

Normal Gauze Bandage Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants With Wound Dehiscence or Infection
Participants with wound dehiscence or infection requiring unplanned dressing changes, antibiotics, or surgery

Secondary Outcome Measures

Full Information

First Posted
December 18, 2016
Last Updated
June 5, 2021
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03000010
Brief Title
Wound Vac Bandage Comparison After Spinal Fusion
Acronym
WV
Official Title
Incisional Vacuum-assisted Closure Therapy After Posterior Spinal Fusion for Pediatric Neuromuscular Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
July 16, 2012 (Actual)
Primary Completion Date
July 17, 2020 (Actual)
Study Completion Date
July 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Scoliosis
Keywords
Wound Vac, Neuromuscular Scoliosis, Posterior Spinal Fusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Incisional Wound Vac
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Normal Gauze Bandage Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Incisional Wound Vac
Other Intervention Name(s)
Incisional vacuum-assisted closure therapy
Intervention Type
Other
Intervention Name(s)
Standard Bandage
Other Intervention Name(s)
Gauze Bandage, Gauze
Primary Outcome Measure Information:
Title
Number of Participants With Wound Dehiscence or Infection
Description
Participants with wound dehiscence or infection requiring unplanned dressing changes, antibiotics, or surgery
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying G Li, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Wound Vac Bandage Comparison After Spinal Fusion

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