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

Study Overview
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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.

Official Title
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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

Conditions
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to See Whether Negative Pressure Wound Therapy Decreases Wound Infections.

Intervention / Treatment
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* Device: Negative Pressure Wound Therapy
* Other: Standard Gauze Treatment


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |