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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Withdrawn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
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring Hypertrophic scarring, Silicone Material, Pressure garments

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 16, 2017
    Last Updated
    May 16, 2017
    Sponsor
    University of Manitoba
    Collaborators
    Health Sciences Centre Foundation, Manitoba
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    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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