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

NCT01135940 | Unknown Phase 2 DMC

• 1 other identifier: H10-00179
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds

Keywords

neuromuscular scoliosis; dermabond; infection; wound closure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Difference in the cosmetic result of the wound closure as measured by the Hollander wound evaluation scale

  12 weeks after surgery

• Difference in the time for final wound closure

  Day of surgery

• Difference in mean caregiver/parental satisfaction scores as measured by a visual analog scale

  12 weeks after surgery

Study Arms (2)

1

EXPERIMENTAL

2-octylcyanoacrylate (Dermabond) closure

Device: 2-octylcyanoacrylate (Dermabond) closure

2

ACTIVE COMPARATOR

Standard staple closure

Device: Standard staple closure

Interventions

2-octylcyanoacrylate (Dermabond) closure DEVICE

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.

1

Standard staple closure DEVICE

Standard procedure for closure of adipose/ subcutaneous layers followed by staple closure

2

Eligibility Criteria

• Age: Up to 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• BCCH Telethon Grant: collaborator

Study Sites (1)

British Columbia Children's Hospital Department of Orthopaedics

Vancouver, British Columbia, V6H 3V4, Canada

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries; Infections

Study Officials

• Firoz Miyanji, MD, FRCSC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Christopher W. Reilly, MD, FRCSC

  University of British Columbia

  STUDY DIRECTOR

• Kishore Mulpuri, MBBS, MS

  University of British Columbia

  STUDY DIRECTOR

Central Study Contacts

Sameer Desai

CONTACT

604-875-2359; sameer.desai@cw.bc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2010
• First Posted: June 3, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 1, 2016

Record last verified: 2016-05

Locations

CA (1)