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

University of British Columbia

Status and phase: Unknown; Phase 2

Conditions: Wounds

Treatments: Device: Standard staple closure; Device: 2-octylcyanoacrylate (Dermabond) closure

Study type: Interventional

Funder types: Other

Identifiers

NCT01135940

H10-00179

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: Under 19 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

1

Experimental group

Description:

2-octylcyanoacrylate (Dermabond) closure

Treatment:

Device: 2-octylcyanoacrylate (Dermabond) closure

2

Active Comparator group

Description:

Standard staple closure

Treatment:

Device: Standard staple closure