Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| BCCH Telethon Grant | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 2-octylcyanoacrylate (Dermabond) closure |
|
| 2 | Active Comparator | Standard staple closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2-octylcyanoacrylate (Dermabond) closure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sameer Desai | Contact | 604-875-2359 | sameer.desai@cw.bc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Firoz Miyanji, MD, FRCSC | University of British Columbia | Principal Investigator |
| Christopher W. Reilly, MD, FRCSC | University of British Columbia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| British Columbia Children's Hospital Department of Orthopaedics | Recruiting | Vancouver | British Columbia | V6H 3V4 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard staple closure | Device | Standard procedure for closure of adipose/ subcutaneous layers followed by staple closure |
|
| 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 |
| 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 |
| Kishore Mulpuri, MBBS, MS |
| University of British Columbia |
| Study Director |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007239 | Infections |
Not provided
Not provided
Not provided