Use of Incisional Negative Pressure Wound Dressing Versus Standard Dry Gauze Dressing for Wound Closure in Patients Undergoing Spinal Surgery - A Multicentre Randomized Control Trial
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 870
- Locations
- 1
- Primary Endpoint
- Wound Infection
Study Overview
Brief Summary
Children with neuromuscular disorders such as cerebral palsy, children with kyphosis and post-traumatic scoliosis have higher infection rates after scoliosis surgery than healthy children who undergo scoliosis surgery. The purpose of our study is to compare the effect of NPWT on infection rates when compared to standard gauze dressing. Participants will be randomized to the "NPWT" or "standard dressing" group. We will compare infection rates between the two groups. We hypothesize participants in the "NPWT" group will have a lower infection rate.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 8 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or female
- •Consent/assent to participate in the study
- •Undergoing posterior spinal surgery categorized as High-Risk for infection, defined as greater than 4% risk of deep or superficial infection based previous reported literature. Procedures qualifying for study are listed below:
- •Kyphosis (any type)
- •Posttraumatic Scoliosis
- •Neuromuscular Scoliosis
Exclusion Criteria
- •Previous incisions over the operative site
- •History of keloid formation
- •Allergy to tape
- •Does not consent/assent to participate in the study
- •Previous or Active Spinal infection
- •Dural tear
- •Hemophiliac
- •Two Stage procedure
- •Unable to follow standard antibiotic protocols
Arms & Interventions
NPWT
subjects will undergo negative pressure wound therapy
Intervention: Negative Pressure Wound Therapy (Device)
Standard Gauze
standard method of using gauze and dressing will be utilized
Intervention: Standard Gauze Treatment (Other)
Outcomes
Primary Outcomes
Wound Infection
Time Frame: up to post op day 14
Wounds will be classified as prolonged discharge if they have persistent sterile drainage on post-op day 5 or after, or as "infected," if cellulitis is found at suture line (erythema \>1cm + tenderness + localized swelling + warmth). Wound assessment will be carried out by a clinical fellow on day 5 and subsequent days till discharge. Patients will also be assessed for other signs of infection such as Fever, Chills, and increase in pain or changes in appetite. Standard infection work-up will be utilized to rule in or rule out infection.
Secondary Outcomes
- Time for wound closure(intraoperatively)
- Cosmetic results(12 weeks post op)
- Wound dehiscence(psot op day 5 to discharge)
- Foreign body reaction(12 weeks post op)
- Caregiver/parental satisfaction(12 weeks post op)