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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Wounds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

2-octylcyanoacrylate (Dermabond) closure

Group Type EXPERIMENTAL

2-octylcyanoacrylate (Dermabond) closure

Intervention Type DEVICE

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.

2

Standard staple closure

Group Type ACTIVE_COMPARATOR

Standard staple closure

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Standard staple closure

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

Intervention Type DEVICE

Eligibility Criteria

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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

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No