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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
870
BC Children's Hospital
Vancouver, British Columbia, Canada
RECRUITINGWound 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.
Time frame: up to post op day 14
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.
Time frame: 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.
Time frame: 12 weeks post op
Caregiver/parental satisfaction
This will analyzed on a visual analog scale (VAS)
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks post op
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