Wound Vac Bandage Comparison After Spinal Fusion

Neuromuscular Scoliosis Clinical Trial

— WV  

Official title:

Incisional Vacuum-assisted Closure Therapy After Posterior Spinal Fusion for Pediatric Neuromuscular Scoliosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03000010
• Other study ID #: HUM00064814
• Status: Completed
• Phase: N/A
• Start date: July 16, 2012
• Est. completion date: July 17, 2020

Study information

• Verified date: June 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 17, 2020
• Est. primary completion date: July 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Scoliosis
• Scoliosis

Intervention

Device:
• Incisional Wound Vac

Other:
• Standard Bandage

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Wound Dehiscence or Infection	Participants with wound dehiscence or infection requiring unplanned dressing changes, antibiotics, or surgery	2 years