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

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

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 Overview

• Status: Unknown
• Conditions: to See Whether Negative Pressure Wound Therapy Decreases Wound Infections.
• Intervention / Treatment: Device: Negative Pressure Wound Therapy; Other: Standard Gauze Treatment

• Study Type: Interventional
• Enrollment (Anticipated): 870
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Recruiting
      • BC Children's Hospital
      • Principal Investigator: Firoz Miyanji, MD
      • Sub-Investigator: Christopher Reilly, MD
      • Contact: Parham Rasoulinejad, MD, MSc; Email: prasoulinejad@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NPWT; subjects will undergo negative pressure wound therapy	Device: Negative Pressure Wound Therapy
Active Comparator: Standard Gauze; standard method of using gauze and dressing will be utilized	Other: Standard Gauze Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Infection	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.	up to post op day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time for wound closure	This will be measured intra-operatively in the operating room from the beginning of deep wound closure till complete skin closure either with standard treatment or by NPWT. Though this outcome measure may not appear to have much value as these surgeries are of a long duration, we considered it important from the surgeon's perspective.	intraoperatively
Cosmetic results	(Hollander wound evaluation scale): This is a validated cosmetic scoring system [8], which gives a score from 0 to 6. The score addresses six clinical variables: step off borders, contour irregularities, scar width, edge inversion, excessive inflammation, and overall cosmetic appearance. Each of these categories is graded on a 0- or 1-point scale where a score of 6 is considered optimal. At 12 weeks post-op follow-up, assessment of the scar will be carried out by an independent investigator who will be blinded to which treatment group the patient belongs to.	12 weeks post op
Caregiver/parental satisfaction	This will analyzed on a visual analog scale (VAS)	12 weeks post op
Wound dehiscence	Any gaping of the spinal wound > 5cm exposing subcutaneous tissue or deeper planes will be considered as indicative of wound dehiscence. This will be looked for at the 5th post- operative day during dressing change till 14 days post-op.	psot op day 5 to discharge
Foreign body reaction	Any evidence of foreign body reaction will be looked for at the two week mark and at 12 weeks post-op follow up. The presence of swelling under the wound over the suture or NPWT site in the absence of fever, significant redness and tenderness will be indicative of foreign body reaction.	12 weeks post op

Collaborators and Investigators

• Sponsor: University of British Columbia

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: February 7, 2014
• First Submitted That Met QC Criteria: May 30, 2016
• First Posted (Estimate): June 3, 2016

Study Record Updates

• Last Update Posted (Estimate): June 3, 2016
• Last Update Submitted That Met QC Criteria: May 30, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Wounds and Injuries; Wound Infection
• Other Study ID Numbers: H13-03020