The Use of Dermabond Versus Standard Staple for Wound Closure in Children With Neuromuscular Scoliosis Undergoing Spinal Deformity Correction Surgery
Primary Purpose
Wounds
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
2-octylcyanoacrylate (Dermabond) closure
Standard staple closure
Sponsored by
About this trial
This is an interventional treatment trial for Wounds focused on measuring neuromuscular scoliosis, dermabond, infection, wound closure
Eligibility 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
Sites / Locations
- British Columbia Children's Hospital Department of OrthopaedicsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
2-octylcyanoacrylate (Dermabond) closure
Standard staple closure
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT01135940
First Posted
June 1, 2010
Last Updated
May 30, 2016
Sponsor
University of British Columbia
Collaborators
BCCH Telethon Grant
1. Study Identification
Unique Protocol Identification Number
NCT01135940
Brief Title
The Use of Dermabond Versus Standard Staple for Wound Closure in Children With Neuromuscular Scoliosis Undergoing Spinal Deformity Correction Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
BCCH Telethon Grant
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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.
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
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds
Keywords
neuromuscular scoliosis, dermabond, infection, wound closure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
2-octylcyanoacrylate (Dermabond) closure
Arm Title
2
Arm Type
Active Comparator
Arm Description
Standard staple closure
Intervention Type
Device
Intervention Name(s)
2-octylcyanoacrylate (Dermabond) closure
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standard staple closure
Intervention Description
Standard procedure for closure of adipose/ subcutaneous layers followed by staple closure
Primary Outcome Measure Information:
Title
Difference in the incidence of wound infection in Dermabond group versus the skin staple group
Description
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.
Time Frame
12 weeks after surgery
Secondary Outcome Measure Information:
Title
Difference in the cosmetic result of the wound closure as measured by the Hollander wound evaluation scale
Description
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.
Time Frame
12 weeks after surgery
Title
Difference in the time for final wound closure
Description
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.
Time Frame
Day of surgery
Title
Difference in mean caregiver/parental satisfaction scores as measured by a visual analog scale
Description
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.
Time Frame
12 weeks after surgery
10. Eligibility
Sex
All
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sameer Desai
Phone
604-875-2359
Email
sameer.desai@cw.bc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Firoz Miyanji, MD, FRCSC
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher W. Reilly, MD, FRCSC
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kishore Mulpuri, MBBS, MS
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
Facility Information:
Facility Name
British Columbia Children's Hospital Department of Orthopaedics
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
The Use of Dermabond Versus Standard Staple for Wound Closure in Children With Neuromuscular Scoliosis Undergoing Spinal Deformity Correction Surgery
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