Negative Pressure Wound Therapy - A Multi-Centered Randomized Control Trial

NCT ID: NCT02790385

Last Updated: 2016-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

870 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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to See Whether Negative Pressure Wound Therapy Decreases Wound Infections.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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NPWT

subjects will undergo negative pressure wound therapy

Group Type EXPERIMENTAL

Negative Pressure Wound Therapy

Intervention Type DEVICE

Standard Gauze

standard method of using gauze and dressing will be utilized

Group Type ACTIVE_COMPARATOR

Standard Gauze Treatment

Intervention Type OTHER

Interventions

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Negative Pressure Wound Therapy

Intervention Type DEVICE

Standard Gauze Treatment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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BC Children's Hospital

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Facility Contacts

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Parham Rasoulinejad, MD, MSc

Role: primary

Other Identifiers

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H13-03020

Identifier Type: -

Identifier Source: org_study_id

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