Clinical trial NCT01135940: The Use of Dermabond Versus Standard Staple for Wound Closure in Children With Neuromuscular Scoliosis Undergoing Spinal Deformity Correction Surgery
Official title: The Use of Dermabond vs. Standard Staple for Wound Closure in Children With Neuromuscular Scoliosis Undergoing Spinal Deformity Correction Surgery: A Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Wounds
Keywords: neuromuscular scoliosis
dermabond
infection
wound closure
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: BCCH Telethon Grant
First posted: 2010-06-03
Enrollment: 80
Sex: ALL
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: Inclusion Criteria:

* male or female 19 years or younger
* neuromuscular scoliosis
* undergoing posterior spinal instrumentation and fusion (one stage)

Exclusion Criteria:

* other non-neuromuscular causes of scoliosis
* previous history of spinal surgery
* previous incision over the operative site
* history of keloid formation
* allergy to superglue
* use of anticoagulation therapy

Primary outcomes:
measure: Difference in the incidence of wound infection in Dermabond group versus the skin staple group
timeFrame: 12 weeks after surgery
Secondary outcomes:
measure: Difference in the cosmetic result of the wound closure as measured by the Hollander wound evaluation scale
timeFrame: 12 weeks after surgery
measure: Difference in the time for final wound closure
timeFrame: Day of surgery
measure: Difference in mean caregiver/parental satisfaction scores as measured by a visual analog scale
timeFrame: 12 weeks after surgery
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital Department of Orthopaedics
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Firoz Miyanji, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Christopher W. Reilly, MD, FRCSC
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Kishore Mulpuri, MBBS, MS
role: STUDY_DIRECTOR
References: