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Negative Pressure Wound Therapy - A Multi-Centered Randomized Control Trial (NPWT)

University of British Columbia logo

University of British Columbia

Status and phase

Unknown
Early Phase 1

Conditions

to See Whether Negative Pressure Wound Therapy Decreases Wound Infections.

Treatments

Other: Standard Gauze Treatment
Device: Negative Pressure Wound Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02790385
H13-03020

Details and patient eligibility

About

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.

Enrollment

870 estimated patients

Sex

All

Ages

8 to 21 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

870 participants in 2 patient groups

NPWT
Experimental group
Description:
subjects will undergo negative pressure wound therapy
Treatment:
Device: Negative Pressure Wound Therapy
Standard Gauze
Active Comparator group
Description:
standard method of using gauze and dressing will be utilized
Treatment:
Other: Standard Gauze Treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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