Recruiting
Phase 2

Dermabond vs. Staple

Sponsor:

University of British Columbia

Code:

NCT01135940

Conditions

Wounds

Eligibility Criteria

Sex: All

Age: 0 - 19

Healthy Volunteers: Not accepted

Interventions

2-octylcyanoacrylate (Dermabond) closure

Standard staple closure

Study Details

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.

Conditions

Wounds

Study ID

NCT01135940

Start date

May, 2010

Status verified date

May, 2016

Completion date

Jun, 2016

Anticipated

Primary completion date

Jun, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 19

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

2-octylcyanoacrylate (Dermabond) closure

active comparator: 2

Standard staple closure

Interventions

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.

Standard staple closure

Standard procedure for closure of adipose/ subcutaneous layers followed by staple closure

Primary outcome measure

  • Difference in the incidence of wound infection in Dermabond group versus the skin staple group [ Time Frame: 12 weeks after surgery ]

Central Contacts and Locations

Central contacts

Sameer Desai

604-875-2359sameer.desai@cw.bc.ca

Locations

British Columbia Children's Hospital Department of Orthopaedics

Recruiting

Vancouver, British Columbia, Canada, V6H 3V4

More Information

Sponsor

University of British Columbia

Last update posted

Jun 1, 2016

Last verified

May, 2016

Keywords

  • neuromuscular scoliosis
  • dermabond
  • infection
  • wound closure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2016-06-01.