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

Wounds Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01135940
• Other study ID #: H10-00179
• Status: Recruiting
• Phase: Phase 2
• First received: June 1, 2010
• Last updated: May 30, 2016
• Start date: May 2010
• Est. completion date: June 2016

Study information

• Verified date: May 2016
• Source: University of British Columbia
• Contact: Sameer Desai
• Phone: 604-875-2359
• Email: sameer.desai[@]cw.bc.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 19 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scoliosis
• Wounds

Intervention

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

Locations

Country	Name	City	State
Canada	British Columbia Children's Hospital Department of Orthopaedics	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	BCCH Telethon Grant

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks after surgery	No
Secondary	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.	12 weeks after surgery	No
Secondary	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.	Day of surgery	No
Secondary	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.	12 weeks after surgery	No