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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of British Columbia
Sponsor:
Collaborator:
BCCH Telethon Grant
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01135940
First received: June 1, 2010
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Wounds
Device: 2-octylcyanoacrylate (Dermabond) closure
Device: Standard staple closure
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Difference in the incidence of wound infection in Dermabond group versus the skin staple group [ Time Frame: 12 weeks after surgery ] [ Designated as safety issue: No ]
    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:
  • Difference in the cosmetic result of the wound closure as measured by the Hollander wound evaluation scale [ Time Frame: 12 weeks after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
    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.

  • Difference in mean caregiver/parental satisfaction scores as measured by a visual analog scale [ Time Frame: 12 weeks after surgery ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: May 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   up to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01135940

Contacts
Contact: Sameer Desai 604-875-2359 sameer.desai@cw.bc.ca

Locations
Canada, British Columbia
British Columbia Children's Hospital Department of Orthopaedics Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
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
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01135940     History of Changes
Other Study ID Numbers: H10-00179
Study First Received: June 1, 2010
Last Updated: June 20, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
neuromuscular scoliosis
dermabond
infection
wound closure

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 20, 2014