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

June 1, 2010
June 20, 2014
May 2010
June 2015   (final data collection date for primary outcome measure)
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.
Difference in the incidence of wound infection in Dermabond group versus the skin staple group [ Time Frame: 4 days 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 cellulitus four or more days post operatively.
Complete list of historical versions of study NCT01135940 on ClinicalTrials.gov Archive Site
  • 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.
  • Difference in the cosmetic result of the wound closure as measured by the Hollander wound evaluation scale [ Time Frame: 4 days 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: 4 days after 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: 4 days 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.
Not Provided
Not Provided
 
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.

  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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Wounds
  • 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.
  • Device: Standard staple closure
    Standard procedure for closure of adipose/ subcutaneous layers followed by staple closure
  • Experimental: 1
    2-octylcyanoacrylate (Dermabond) closure
    Intervention: Device: 2-octylcyanoacrylate (Dermabond) closure
  • Active Comparator: 2
    Standard staple closure
    Intervention: Device: Standard staple closure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
up to 19 Years
No
Contact: Sameer Desai 604-875-2359 sameer.desai@cw.bc.ca
Canada
 
NCT01135940
H10-00179
Yes
University of British Columbia
University of British Columbia
BCCH Telethon Grant
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
University of British Columbia
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP