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The Use of Dermabond Versus Standard Staple for Wound Closure in Children With Neuromuscular Scoliosis Undergoing Spinal Deformity Correction Surgery

2014-07-23 21:08:54 | BioPortfolio

Summary

This is a prospective, Phase II (hypothesis generating) randomized pilot study investigating the efficacy of using Dermabond as a method of final wound closure as compared to the standard staple method in children with Neuromuscular Scoliosis undergoing spinal deformity correction surgery.

Description

1. To explore whether there is a difference in the incidence of wound infection in the Dermabond group vs. the skin staple group as measured by microbiological culture four days post-operatively. Wound infection is defined as prolonged sterile discharge (>4 days), positive wound cultures, or cellulitis four or more days post-operatively.

2. To explore whether there is a difference in the cosmetic result of the wound closure as measured by the Hollander wound evaluation scale. Our hypothesis is that the Dermabond group will have a better cosmetic result. Secondary outcome

3. To explore whether there is a difference in the time for final wound closure. Our hypothesis is that the Dermabond group will have a shorter time for final wound closure. Secondary outcome

4. To explore whether there is a difference in mean caregiver/parental satisfaction scores as measured by a visual analog scale. Our hypothesis is that parental satisfaction will be higher in the Dermabond group. Secondary outcome

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Wounds

Intervention

2-octylcyanoacrylate (Dermabond) closure, Standard staple closure

Location

British Columbia Children's Hospital Department of Orthopaedics
Vancouver
British Columbia
Canada
V6H 3V4

Status

Recruiting

Source

University of British Columbia

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:54-0400

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