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

The Use of Dermabond vs. Standard Staple for Wound Closure in Children With Neuromuscular Scoliosis Undergoing Spinal Deformity Correction Surgery: A Phase II Study

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.

Study Overview

• Status: Unknown
• Conditions: Wounds
• Intervention / Treatment: Device: 2-octylcyanoacrylate (Dermabond) closure; Device: Standard staple closure

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 15 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 2-octylcyanoacrylate (Dermabond) closure	Device: 2-octylcyanoacrylate (Dermabond) closure; Standard procedure for closure of adipose/ subcutaneous layers. The subcuticular layer will be closed with a continuous 2-0 vicryl suture which will then be followed by Dermabond closure.
Active Comparator: 2; Standard staple closure	Device: Standard staple closure; Standard procedure for closure of adipose/ subcutaneous layers followed by staple closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in the incidence of wound infection in Dermabond group versus the skin staple group	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.	12 weeks after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: BCCH Telethon Grant
• Investigators: Principal Investigator: Firoz Miyanji, MD, FRCSC, University of British Columbia; Study Director: Christopher W. Reilly, MD, FRCSC, University of British Columbia; Study Director: Kishore Mulpuri, MBBS, MS, University of British Columbia

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: June 1, 2010
• First Submitted That Met QC Criteria: June 2, 2010
• First Posted (Estimate): June 3, 2010

Study Record Updates

• Last Update Posted (Estimate): June 1, 2016
• Last Update Submitted That Met QC Criteria: May 30, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: infection; wound closure; dermabond; neuromuscular scoliosis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Wounds and Injuries; Scoliosis
• Other Study ID Numbers: H10-00179