Neuromuscular Scoliosis
Conditions
Keywords
Wound Vac, Neuromuscular Scoliosis, Posterior Spinal Fusion
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.
Interventions
DEVICEIncisional Wound Vac
OTHERStandard Bandage
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Wound Dehiscence or Infection | 2 years | Participants with wound dehiscence or infection requiring unplanned dressing changes, antibiotics, or surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Incisional Wound Vac | 21 |
| 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.
Standard Bandage | 20 |
| Total | 41 |
Baseline characteristics
| Characteristic | Incisional Wound Vac | Normal Gauze Bandage Group | Total |
|---|---|---|---|
| Age, Continuous | 13.5 years STANDARD_DEVIATION 1.6 | 12.6 years STANDARD_DEVIATION 2.7 | 13 years STANDARD_DEVIATION 2.3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 14 Participants |
| Sex: Female, Male Male | 16 Participants | 11 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 21 | 2 / 20 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants With Wound Dehiscence or Infection
Participants with wound dehiscence or infection requiring unplanned dressing changes, antibiotics, or surgery
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Incisional Wound Vac | Number of Participants With Wound Dehiscence or Infection | 0 Participants |
| Normal Gauze Bandage Group | Number of Participants With Wound Dehiscence or Infection | 0 Participants |