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

Sponsor

University of British Columbia (Other)

Overall Status

Unknown status

CT.gov ID

NCT01135940

Collaborator

BCCH Telethon Grant (Other)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Wounds	Device: 2-octylcyanoacrylate (Dermabond) closure Device: Standard staple closure	Phase 2

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

May 1, 2010

Anticipated Primary Completion Date :

Jun 1, 2016

Anticipated Study Completion Date :

Jun 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Difference in the incidence of wound infection in Dermabond group versus the skin staple group [12 weeks after surgery]
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 [12 weeks after surgery]
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 [Day of surgery]
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 [12 weeks after surgery]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	British Columbia Children's Hospital Department of Orthopaedics	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