WoundsPhase 2NCT01135940
The Use of Dermabond Versus Standard Staple for Wound Closure in Children With Neuromuscular Scoliosis Undergoing Spinal Deformity Correction Surgery
A Phase 2 study testing 2-octylcyanoacrylate (Dermabond) closure and Standard staple closure in people with Wounds, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 19 years
- Conditions the study is for
- Wounds
- What is being tested?
- 2-octylcyanoacrylate (Dermabond) closure and Standard staple closure
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- May 2010to Jun 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- male or female 19 years or younger
- neuromuscular scoliosis
- undergoing posterior spinal instrumentation and fusion (one stage)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
British Columbia Children's Hospital Department of Orthopaedics
Vancouver, British Columbia, V6H 3V4
About this study
Official title: The Use of Dermabond vs. Standard Staple for Wound Closure in Children With Neuromuscular Scoliosis Undergoing Spinal Deformity Correction Surgery: A Phase II Study
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.
Read the detailed description
- 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.
- 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
- 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
- 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
- Wounds
- Being tested
- 2-octylcyanoacrylate (Dermabond) closure, Standard staple closure
- Keywords
- neuromuscular scoliosis, dermabond, infection, wound closure
- Medical subject headings
- Wounds and Injuries, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-octylcyanoacrylate (Dermabond) closureDevice
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.
Standard staple closureDevice
Standard procedure for closure of adipose/ subcutaneous layers followed by staple closure
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 2-octylcyanoacrylate (Dermabond) closure Receives: Device: 2-octylcyanoacrylate (Dermabond) closure |
| 2 | Active comparator | Standard staple closure Receives: Device: Standard staple closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks after surgery
Secondary outcomes (3)
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.
Measured: 12 weeks after surgery
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.
Measured: 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.
Measured: 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- BCCH Telethon Grant
- Responsible party
- Sponsor
- Investigators
- Firoz Miyanji, MD, FRCSC, Principal investigator, University of British ColumbiaChristopher W. Reilly, MD, FRCSC, Study director, University of British ColumbiaKishore Mulpuri, MBBS, MS, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135940
- Sponsor's protocol ID
- H10-00179
- Status last verified
- May 2016
- First submitted
- 1 Jun 2010
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Dermabond vs. Standard Staple for Wound Closure in Children With Neuromuscular Scoliosis Undergoing Spinal Deformity Correction Surgery: A Phase II Study
- ClinicalTrials.gov ID
- NCT01135940
- Acronym / sponsor ID
- H10-00179
- Conditions
- Wounds
- Keywords
- neuromuscular scoliosis, dermabond, infection, wound closure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- BCCH Telethon Grant
- Study start
- May 2010
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 3 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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
- 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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: 2-octylcyanoacrylate (Dermabond) closure2-octylcyanoacrylate (Dermabond) closure |
| 2 | Active comparator | Device: Standard staple closureStandard staple closure |
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- male or female 19 years or younger
- neuromuscular scoliosis
- undergoing posterior spinal instrumentation and fusion (one stage)
Key exclusion criteria (6 listed)
- other non-neuromuscular causes of scoliosis
- previous history of spinal surgery
- previous incision over the operative site
- history of keloid formation
- allergy to superglue
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-octylcyanoacrylate (Dermabond) closureStandard 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. | Device | 1 |
| Standard staple closureStandard procedure for closure of adipose/ subcutaneous layers followed by staple closure | Device | 2 |
Primary outcome
Difference in the incidence of wound infection in Dermabond group versus the skin staple group
Time frame: 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.
3 secondary outcomes
Difference in the cosmetic result of the wound closure as measured by the Hollander wound evaluation scale
Time frame: 12 weeks after surgery
Difference in the time for final wound closure
Time frame: Day of surgery
Difference in mean caregiver/parental satisfaction scores as measured by a visual analog scale
Time frame: 12 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Firoz Miyanji, MD, FRCSC principal investigator
University of British Columbia
Christopher W. Reilly, MD, FRCSC study director
University of British Columbia
Kishore Mulpuri, MBBS, MS study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2-octylcyanoacrylate (Dermabond) closure and Standard staple closure in people with Wounds, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sameer Desai (604-875-2359, sameer.desai@cw.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the incidence of wound infection in Dermabond group versus the skin staple group (time frame: 12 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016.