Back to resultsNegative Pressure Wound Therapy - A Multi-Centered Randomized Control Trial (NPWT)
Primary Purpose
to See Whether Negative Pressure Wound Therapy Decreases Wound Infections.
Status
Unknown status
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Negative Pressure Wound Therapy
Standard Gauze Treatment
Sponsored by
About this trial
This is an interventional prevention trial for to See Whether Negative Pressure Wound Therapy Decreases Wound Infections.
Eligibility Criteria
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
Sites / Locations
- BC Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NPWT
Standard Gauze
Arm Description
subjects will undergo negative pressure wound therapy
standard method of using gauze and dressing will be utilized
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Caregiver/parental satisfaction
This will analyzed on a visual analog scale (VAS)
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.
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.
Full Information
NCT ID
NCT02790385
First Posted
February 7, 2014
Last Updated
May 30, 2016
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT02790385
Brief Title
Negative Pressure Wound Therapy - A Multi-Centered Randomized Control Trial
Acronym
NPWT
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
to See Whether Negative Pressure Wound Therapy Decreases Wound Infections.
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
870 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NPWT
Arm Type
Experimental
Arm Description
subjects will undergo negative pressure wound therapy
Arm Title
Standard Gauze
Arm Type
Active Comparator
Arm Description
standard method of using gauze and dressing will be utilized
Intervention Type
Device
Intervention Name(s)
Negative Pressure Wound Therapy
Intervention Type
Other
Intervention Name(s)
Standard Gauze Treatment
Primary Outcome Measure Information:
Title
Wound Infection
Description
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.
Time Frame
up to post op day 14
Secondary Outcome Measure Information:
Title
Time for wound closure
Description
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.
Time Frame
intraoperatively
Title
Cosmetic results
Description
(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.
Time Frame
12 weeks post op
Title
Caregiver/parental satisfaction
Description
This will analyzed on a visual analog scale (VAS)
Time Frame
12 weeks post op
Title
Wound dehiscence
Description
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.
Time Frame
psot op day 5 to discharge
Title
Foreign body reaction
Description
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.
Time Frame
12 weeks post op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
BC Children's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Parham Rasoulinejad, MD, MSc
Email
prasoulinejad@gmail.com
First Name & Middle Initial & Last Name & Degree
Firoz Miyanji, MD
First Name & Middle Initial & Last Name & Degree
Christopher Reilly, MD
12. IPD Sharing Statement
Learn more about this trial
Negative Pressure Wound Therapy - A Multi-Centered Randomized Control Trial
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