Wound Vac Bandage Comparison After Spinal Fusion
WV
Incisional Vacuum-assisted Closure Therapy After Posterior Spinal Fusion for Pediatric Neuromuscular Scoliosis
1 other identifier
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 16, 2012
CompletedFirst Submitted
Initial submission to the registry
December 18, 2016
CompletedFirst Posted
Study publicly available on registry
December 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 17, 2020
CompletedResults Posted
Study results publicly available
June 28, 2021
CompletedJune 28, 2021
June 1, 2021
8 years
December 18, 2016
June 5, 2021
June 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Wound Dehiscence or Infection
Participants with wound dehiscence or infection requiring unplanned dressing changes, antibiotics, or surgery
2 years
Study Arms (2)
Incisional Wound Vac
ACTIVE COMPARATORWe 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
ACTIVE COMPARATORWe 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.
Interventions
Eligibility Criteria
You may qualify if:
- any patient 17 years and younger
- neuromuscular scoliosis undergoing posterior spinal fusion
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Results Point of Contact
- Title
- G. Ying Li
- Organization
- University of Michigan
Study Officials
- PRINCIPAL INVESTIGATOR
Ying G Li, MD
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
December 18, 2016
First Posted
December 21, 2016
Study Start
July 16, 2012
Primary Completion
July 17, 2020
Study Completion
July 17, 2020
Last Updated
June 28, 2021
Results First Posted
June 28, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share