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.

Verified January 2013 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: January 17, 2013

Last verified: January 2013

History of Changes

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:

MedlinePlus related topics: Scoliosis

U.S. FDA Resources

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:	February 2014
Estimated Primary Completion Date:	January 2014 (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:

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

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

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

Contacts

Contact: Jill Kennedy

604-875-2359

jill.kennedy@cw.bc.ca

Locations

Canada, British Columbia
British Columbia Children's Hospital Department of Orthopaedics	Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Jill Kennedy 604-875-2359 jill.kennedy@cw.bc.ca

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:	January 17, 2013
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 May 22, 2013

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