Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03000010
Study type Interventional
Source University of Michigan
Contact
Status Completed
Phase N/A
Start date July 16, 2012
Completion date July 17, 2020

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06023043 - Postoperative Steroid Use in Adolescent Idiopathic Scoliosis and Neuromuscular Scoliosis Patients Phase 4
Completed NCT04021784 - Limited-efficacy Testing of SDS and NEMOST for Early Onset Neuromuscular Scoliosis N/A
Recruiting NCT04764812 - Determination of Risk Factors and Awareness Associated With Development of Neuromuscular Scoliosis
Completed NCT01645111 - An Open-label Trial of Clevidipine for Controlled Hypotension During Spinal Fusion Phase 2/Phase 3
Not yet recruiting NCT06367933 - Mini-invasive Spine Surgery for Neuromuscolar Scoliosis N/A
Completed NCT03863496 - Efficacy of Surgical Treatment by Different Pedicle Screw Systems in Pediatric Neuromuscular Spinal Deformity N/A
Recruiting NCT06042699 - Scoliosis Iron Supplementation Study N/A
Active, not recruiting NCT04969770 - Contribution of Muscle and Disc Elastography in the Evaluation of Biomechanical Modifications of the Neuromuscular Spine Fixed by Bipolar Construct N/A
Recruiting NCT05281757 - Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Complex
Recruiting NCT05071144 - Spine Procedures Assisted With RoboTics And Navigation
Completed NCT04012112 - The Effect of Flexible Thoracolumbar Brace on Spinal Alignment, Pain and Quality of Life in Subjects With Neuromuscular Scoliosis N/A
Terminated NCT02670798 - Thromboelastography Transfusion Protocol for Pediatric Neuromuscular Scoliosis Surgery N/A
Completed NCT03862625 - Seating System for Scoliosis in Non-ambulatory Children With Cerebral Palsy: A Pilot Randomized Controlled Trial N/A