The Use of Dermabond Versus Standard Staple for Wound Closure in Children With Neuromuscular Scoliosis Undergoing Spinal Deformity Correction Surgery
This study is currently recruiting participants.
Verified January 2013 by University of British Columbia
Sponsor:
University of British Columbia
Collaborator:
BCCH Telethon Grant
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01135940
First received: June 1, 2010
Last updated: January 17, 2013
Last verified: January 2013
| Tracking Information | |||||||||||||
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| First Received Date ICMJE | June 1, 2010 | ||||||||||||
| Last Updated Date | January 17, 2013 | ||||||||||||
| Start Date ICMJE | May 2010 | ||||||||||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Difference in the incidence of wound infection in Dermabond group versus the skin staple group [ Time Frame: 12 weeks after surgery ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE |
Difference in the incidence of wound infection in Dermabond group versus the skin staple group [ Time Frame: 4 days after surgery ] [ Designated as safety issue: No ] 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 cellulitus four or more days post operatively. |
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| Change History | Complete list of historical versions of study NCT01135940 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | The Use of Dermabond Versus Standard Staple for Wound Closure in Children With Neuromuscular Scoliosis Undergoing Spinal Deformity Correction Surgery | ||||||||||||
| Official Title ICMJE | The Use of Dermabond vs. Standard Staple for Wound Closure in Children With Neuromuscular Scoliosis Undergoing Spinal Deformity Correction Surgery: A Phase II Study | ||||||||||||
| 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. |
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| Detailed Description |
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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Phase 2 | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Wounds | ||||||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 80 | ||||||||||||
| Estimated Completion Date | February 2014 | ||||||||||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | up to 19 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT01135940 | ||||||||||||
| Other Study ID Numbers ICMJE | H10-00179 | ||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||
| Responsible Party | University of British Columbia | ||||||||||||
| Study Sponsor ICMJE | University of British Columbia | ||||||||||||
| Collaborators ICMJE | BCCH Telethon Grant | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | University of British Columbia | ||||||||||||
| Verification Date | January 2013 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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