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

Sponsor
University of British Columbia (Other)
Overall Status
Unknown status
CT.gov ID
NCT02790385
Collaborator
(none)
870
Enrollment
1
Location
2
Arms
60
Duration (Months)
14.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Negative Pressure Wound Therapy
  • Other: Standard Gauze Treatment
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
870 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
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 Start Date :
Jul 1, 2014
Anticipated Primary Completion Date :
Jul 1, 2019
Anticipated Study Completion Date :
Jul 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Wound Infection [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 Outcome Measures

  1. Time for wound closure [intraoperatively]

    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.

  2. Cosmetic results [12 weeks post op]

    (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.

  3. Caregiver/parental satisfaction [12 weeks post op]

    This will analyzed on a visual analog scale (VAS)

  4. Wound dehiscence [psot op day 5 to discharge]

    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.

  5. Foreign body reaction [12 weeks post op]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 21 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 BC Children's Hospital Vancouver British Columbia Canada

Sponsors and Collaborators

  • University of British Columbia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT02790385
Other Study ID Numbers:
  • H13-03020
First Posted:
Jun 3, 2016
Last Update Posted:
Jun 3, 2016
Last Verified:
May 1, 2016
Additional relevant MeSH terms:
Wound Infection
Wounds and Injuries

Study Results

No Results Posted as of Jun 3, 2016