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

Phase 2

• Conditions: Wounds
• Interventions: Device: 2-octylcyanoacrylate (Dermabond) closure; Device: Standard staple closure

• Registration Number: NCT01135940
• Lead Sponsor: University of British Columbia

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

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-01
• Study First Submitted QC: 2010-06-02
• Study First Posted: 2010-06-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-30
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Last Update Posted: 2016-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	2-octylcyanoacrylate (Dermabond) closure	2-octylcyanoacrylate (Dermabond) closure
2	Standard staple closure	Standard staple closure

Primary Outcome Measures

Name	Time	Method
Difference in the incidence of wound infection in Dermabond group versus the skin staple group	12 weeks after surgery	To explore whether there is a difference in the incidence of wound infection in Dermabond group versus the skin staple group as measured by microbiological culture taken 4 days post-operatively. Wound infection is defined as prolonged sterile discharge , positive wound cultures, or cellulitis four or more days post-operatively.

Secondary Outcome Measures

Name	Time	Method
Difference in mean caregiver/parental satisfaction scores as measured by a visual analog scale	12 weeks after surgery	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.
Difference in the cosmetic result of the wound closure as measured by the Hollander wound evaluation scale	12 weeks after surgery	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.
Difference in the time for final wound closure	Day of surgery	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.

Trial Locations

Locations (1)

British Columbia Children's Hospital Department of Orthopaedics; 🇨🇦 Vancouver, British Columbia, Canada