Wound Vac Bandage Comparison After Spinal Fusion (WV)

University of Michigan

Status: Completed

Conditions: Neuromuscular Scoliosis

Treatments: Device: Incisional Wound Vac; Other: Standard Bandage

Study type: Interventional

Funder types: Other

Identifiers

NCT03000010

HUM00064814

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: Under 17 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

41 participants in 2 patient groups

Incisional Wound Vac

Active Comparator group

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.

Treatment:

Device: Incisional Wound Vac

Normal Gauze Bandage Group

Active Comparator group

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.

Treatment:

Other: Standard Bandage