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Wound Vac Bandage Comparison After Spinal Fusion (WV)

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ClinicalTrials.gov Identifier: NCT03000010
Recruitment Status : Recruiting
First Posted : December 21, 2016
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
G Ying Li, 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.

Condition or disease Intervention/treatment Phase
Neuromuscular Scoliosis Device: Incisional Wound Vac Other: Standard Bandage Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Incisional Vacuum-assisted Closure Therapy After Posterior Spinal Fusion for Pediatric Neuromuscular Scoliosis
Actual Study Start Date : July 16, 2012
Estimated Primary Completion Date : July 28, 2020
Estimated Study Completion Date : July 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Device: Incisional Wound Vac
Other Name: Incisional vacuum-assisted closure therapy

Active Comparator: Normal Gauze Bandage Group
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.
Other: Standard Bandage
Other Names:
  • Gauze Bandage
  • Gauze




Primary Outcome Measures :
  1. Prevention of wound dehiscence or infection [ Time Frame: 2 years ]
    wound dehiscence or infection requiring unplanned dressing changes, antibiotics, or surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03000010


Contacts
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Contact: JennyLee Swallow 734-615-8263 JSTS@med.umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Michelle Burke, MS    734-647-9663    mcburke@med.umich.edu   
Principal Investigator: Ying G Li, MD         
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Ying G Li, MD University of Michigan
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Responsible Party: G Ying Li, MD, University of Michigan
ClinicalTrials.gov Identifier: NCT03000010    
Other Study ID Numbers: HUM00064814
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by G Ying Li, University of Michigan:
Wound Vac
Neuromuscular Scoliosis
Posterior Spinal Fusion
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases