Study of Silicone Material Inserts To Treat Burn Scars
Primary Purpose
Burns
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pressure garment and silicone insert
Pressure garment
Sponsored by
About this trial
This is an interventional treatment trial for Burns focused on measuring Hypertrophic scarring, Silicone Material, Pressure garments
Eligibility Criteria
Inclusion Criteria:
- patients who would normally receive pressure garments
- presence of an acute burn to an upper or lower extremity that requires treatment with a sheet or meshed graft
- Minimum 4% total body surface area graft dimension (this must include areas above and below the elbow or on medial and lateral aspects of the calf
- Between 16 years and 60 years of age
- Patient must consent to the study or obtain consent from guardian if <18 years of age
- Must be available for follow-up at 1 month, 3 months, 6 months, and 12 months post initiation of treatment
Exclusion Criteria:
- Presence of pre-existing hypertrophic or keloid scarring
- Pressure garments initiated greater than 2 months post discharge from hospital
- Pre-existing decrease in range of motion of affected extremity
- One treatment area with a prolonged healing phase or which had been treated differently in comparison to adjacent treatment area
- Patient unable to comprehend or participate in self reporting
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pressure garment and silicone insert
Pressure Garment
Arm Description
Custom measured pressure garment with a textile bonded silicone insert in either the distal or proximal portion of the pressure garment, to be worn 23 hours per day.
Custom measured pressure garment, to be worn 23 hours per day.
Outcomes
Primary Outcome Measures
Scar pliability measured in gm/mm squared
The Modified Vancouver Scar Scale (MVSS) will be used to measure the scar pliability. It is a therapist-judged hand held tool that measure scar properties on an ordinal scale. Because the MVSS is a subjective rating system, we will also be using the NK Skin Compliance Device (SCD)to measure scar pliability. It is a non-invasive hand-held device that measures skin compliance or pliability.
Secondary Outcome Measures
Scar vascularity
The Modified Vancouver Scar Scale (MVSS) will be used to measure the scar pliability. It is a therapist-judged hand held tool that measure scar properties on an ordinal scale.
Full Information
NCT ID
NCT03159182
First Posted
May 16, 2017
Last Updated
May 16, 2017
Sponsor
University of Manitoba
Collaborators
Health Sciences Centre Foundation, Manitoba
1. Study Identification
Unique Protocol Identification Number
NCT03159182
Brief Title
Study of Silicone Material Inserts To Treat Burn Scars
Official Title
Effectiveness of Silicone Material Inserts Within Pressure Garments in the Treatment of Hypertrophic Burn Scars
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Why Stopped
First required to complete a proof of principle study for a new outcome measure.
Study Start Date
September 2018 (Anticipated)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
March 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
Health Sciences Centre Foundation, Manitoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if the use of silicone material inserts within pressure garments is effective in decreasing hypertrophic burn scar formation as compared to standard pressure garment therapy.
Detailed Description
Surgical revision, potential hospitalization, and extensive post-surgical rehabilitation may be required for the revision and correction of hypertrophic burn scars to restore function and prevent disability. This in turn results in an increased financial burden to the medical system. More importantly, the patient is required to undergo an additional invasive medical procedure that can potentially create further hypertrophic scarring.
Prevention and reduction of hypertrophic scars with non-invasive, cost effective, and evidence based treatment modalities is therefore the most desirable approach. Two of the most generally accepted methods of non-invasive treatment, pressure garments and silicone gel sheeting, have been demonstrated to individually treat hypertrophic scarring. Recently, burn therapists have begun to use silicone bonded material inserts within pressure garments following the logical deduction that the two therapeutic techniques can be combined to resolve many of the cited individual disadvantages, while reaping the benefits of each individual modality. It is the aim of this study to determine the efficacy of these silicone bonded material inserts within pressure garments in the treatment of hypertrophic scarring.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Hypertrophic scarring, Silicone Material, Pressure garments
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pressure garment and silicone insert
Arm Type
Experimental
Arm Description
Custom measured pressure garment with a textile bonded silicone insert in either the distal or proximal portion of the pressure garment, to be worn 23 hours per day.
Arm Title
Pressure Garment
Arm Type
Active Comparator
Arm Description
Custom measured pressure garment, to be worn 23 hours per day.
Intervention Type
Device
Intervention Name(s)
Pressure garment and silicone insert
Intervention Description
Custom made fabric pressure garment with textile bonded silicone insert on either proximal or distal portion of pressure garment.
Intervention Type
Device
Intervention Name(s)
Pressure garment
Intervention Description
Custom made fabric pressure garment
Primary Outcome Measure Information:
Title
Scar pliability measured in gm/mm squared
Description
The Modified Vancouver Scar Scale (MVSS) will be used to measure the scar pliability. It is a therapist-judged hand held tool that measure scar properties on an ordinal scale. Because the MVSS is a subjective rating system, we will also be using the NK Skin Compliance Device (SCD)to measure scar pliability. It is a non-invasive hand-held device that measures skin compliance or pliability.
Time Frame
A baseline evaluation will be performed at the time of initial pressure garment fitting, and follow up evaluations will take place at 1 month, 3 months, 6 months and 12 months after pressure garment fitting.
Secondary Outcome Measure Information:
Title
Scar vascularity
Description
The Modified Vancouver Scar Scale (MVSS) will be used to measure the scar pliability. It is a therapist-judged hand held tool that measure scar properties on an ordinal scale.
Time Frame
A baseline evaluation will be performed at the time of initial pressure garment fitting, and follow up evaluations will take place at 1 month, 3 months, 6 months and 12 months after pressure garment fitting.
Other Pre-specified Outcome Measures:
Title
Scar height
Description
The Modified Vancouver Scar Scale (MVSS) will be used to measure the scar pliability. It is a therapist-judged hand held tool that measure scar properties on an ordinal scale.
Time Frame
A baseline evaluation will be performed at the time of initial pressure garment fitting, and follow up evaluations will take place at 1 month, 3 months, 6 months and 12 months after pressure garment fitting.
Title
Scar itch
Description
Scar itch will be measured using a visual analogue scale (VAS).
Time Frame
A baseline evaluation will be performed at the time of initial pressure garment fitting, and follow up evaluations will take place at 1 month, 3 months, 6 months and 12 months after pressure garment fitting.
Title
Scar Appearance
Description
Will be measured using a visual analogue scale (VAS).
Time Frame
A baseline evaluation will be performed at the time of initial pressure garment fitting, and follow up evaluations will take place at 1 month, 3 months, 6 months and 12 months after pressure garment fitting.
Title
Comfort of garment
Description
Will be measured using ordered response scales.
Time Frame
A baseline evaluation will be performed at the time of initial pressure garment fitting, and follow up evaluations will take place at 1 month, 3 months, 6 months and 12 months after pressure garment fitting.
Title
Limitations to movement
Description
Will be measured using ordered response scales.
Time Frame
A baseline evaluation will be performed at the time of initial pressure garment fitting, and follow up evaluations will take place at 1 month, 3 months, 6 months and 12 months after pressure garment fitting.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients who would normally receive pressure garments
presence of an acute burn to an upper or lower extremity that requires treatment with a sheet or meshed graft
Minimum 4% total body surface area graft dimension (this must include areas above and below the elbow or on medial and lateral aspects of the calf
Between 16 years and 60 years of age
Patient must consent to the study or obtain consent from guardian if <18 years of age
Must be available for follow-up at 1 month, 3 months, 6 months, and 12 months post initiation of treatment
Exclusion Criteria:
Presence of pre-existing hypertrophic or keloid scarring
Pressure garments initiated greater than 2 months post discharge from hospital
Pre-existing decrease in range of motion of affected extremity
One treatment area with a prolonged healing phase or which had been treated differently in comparison to adjacent treatment area
Patient unable to comprehend or participate in self reporting
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara-Jane Milne, BMR(OT)
Organizational Affiliation
Winnipeg Health Sciences Centre
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
8537427
Citation
Baryza MJ, Baryza GA. The Vancouver Scar Scale: an administration tool and its interrater reliability. J Burn Care Rehabil. 1995 Sep-Oct;16(5):535-8. doi: 10.1097/00004630-199509000-00013.
Results Reference
background
PubMed Identifier
2529659
Citation
Ahn ST, Monafo WW, Mustoe TA. Topical silicone gel: a new treatment for hypertrophic scars. Surgery. 1989 Oct;106(4):781-6; discussion 786-7.
Results Reference
result
PubMed Identifier
18182896
Citation
Allely RR, Van-Buendia LB, Jeng JC, White P, Wu J, Niszczak J, Jordan MH. Laser Doppler imaging of cutaneous blood flow through transparent face masks: a necessary preamble to computer-controlled rapid prototyping fabrication with submillimeter precision. J Burn Care Res. 2008 Jan-Feb;29(1):42-8. doi: 10.1097/BCR.0b013e31815f6eeb.
Results Reference
result
Citation
Al-Mandeel, MS, Bang, R.L., & Ebrahim, M.K. Re-appraisal of cica-care (silicone gel sheet) in ther treatment of hypertrophic and keloid scars. Saudi Medical Journal 19(6):741-745, 1998.
Results Reference
result
PubMed Identifier
3220875
Citation
Bartell TH, Monafo WW, Mustoe TA. A new instrument for serial measurements of elasticity in hypertrophic scar. J Burn Care Rehabil. 1988 Nov-Dec;9(6):657-60. doi: 10.1097/00004630-198811000-00021.
Results Reference
result
PubMed Identifier
1003586
Citation
Baur PS, Larson DL, Stacey TR, Barratt GF, Dobrkovsky M. Ultrastructural analysis of pressure-treated human hypertrophic scars. J Trauma. 1976 Dec;16(12):958-67. doi: 10.1097/00005373-197612000-00004. No abstract available.
Results Reference
result
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Study of Silicone Material Inserts To Treat Burn Scars
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