Wounds
Conditions
Keywords
neuromuscular scoliosis, dermabond, infection, wound closure
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.
Detailed 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
Interventions
DEVICE2-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.
DEVICEStandard staple closure
Standard procedure for closure of adipose/ subcutaneous layers followed by staple closure
Sponsors
BCCH Telethon Grant
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 19 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the incidence of wound infection in Dermabond group versus the skin staple group | 12 weeks after surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Difference in the cosmetic result of the wound closure as measured by the Hollander wound evaluation scale | 12 weeks after surgery | 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 | Day of surgery | 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 | 12 weeks after surgery | 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. |
Countries
Canada
Contacts
Primary ContactSameer Desai
Outcome results
None listed