BurnsNCT03159182
Study of Silicone Material Inserts To Treat Burn Scars
A study testing Pressure garment and silicone insert and Pressure garment in people with Burns, run by University of Manitoba.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Burns
- What is being tested?
- Pressure garment and silicone insert and Pressure garment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to Mar 2020
- Phase
- Interventional
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Effectiveness of Silicone Material Inserts Within Pressure Garments in the Treatment of Hypertrophic Burn Scars
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.
Read the 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.
- Conditions
- Burns
- Being tested
- Pressure garment and silicone insert, Pressure garment
- Keywords
- Hypertrophic scarring, Silicone Material, Pressure garments
- Medical subject headings
- Burns, Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure garment and silicone insertDevice
Custom made fabric pressure garment with textile bonded silicone insert on either proximal or distal portion of pressure garment.
Pressure garmentDevice
Custom made fabric pressure garment
| Study group | Role | What they receive |
|---|---|---|
| Pressure garment and silicone insert | Experimental | 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. Receives: Device: Pressure garment and silicone insert |
| Pressure Garment | Active comparator | Custom measured pressure garment, to be worn 23 hours per day. Receives: Device: Pressure garment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (1)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study startSep 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionMar 2020 (estimated)
Why it stopped: First required to complete a proof of principle study for a new outcome measure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Health Sciences Centre Foundation, Manitoba
- Responsible party
- Principal investigator, Sara-Jane Milne, University of Manitoba
- Investigators
- Sara-Jane Milne, BMR(OT), Principal investigator, Winnipeg Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159182
- Sponsor's protocol ID
- B2008:056
- Status last verified
- May 2017
- First submitted
- 16 May 2017
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 8537427Ahn ST, Monafo WW, Mustoe TA. Topical silicone gel: a new treatment for hypertrophic scars. Surgery. 1989 Oct;106(4):781-6; discussion 786-7.
PubMed 2529659Allely 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.
PubMed 18182896Al-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.
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.
PubMed 3220875Baur 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.
PubMed 1003586
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Silicone Material Inserts Within Pressure Garments in the Treatment of Hypertrophic Burn Scars
- ClinicalTrials.gov ID
- NCT03159182
- Acronym / sponsor ID
- B2008:056
- Conditions
- Burns
- Keywords
- Hypertrophic scarring, Silicone Material, Pressure garments
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: First required to complete a proof of principle study for a new outcome measure.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Health Sciences Centre Foundation, Manitoba
- Study start
- Sep 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 18 May 2017 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pressure garment and silicone insert | Experimental | Device: Pressure garment and silicone insertCustom 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. |
| Pressure Garment | Active comparator | Device: Pressure garmentCustom measured pressure garment, to be worn 23 hours per day. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Pressure garment and silicone insertCustom made fabric pressure garment with textile bonded silicone insert on either proximal or distal portion of pressure garment. | Device | Pressure garment and silicone insert |
| Pressure garmentCustom made fabric pressure garment | Device | Pressure Garment |
Primary outcome
Scar pliability measured in gm/mm squared
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.
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.
1 secondary outcome
Scar vascularity
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
- Background: PubMed 8537427Baryza 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 publication: PubMed 2529659Ahn 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 publication: PubMed 18182896Allely 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 publicationAl-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 publication: PubMed 3220875Bartell 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 publication: PubMed 1003586Baur 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.
- Individual participant dataSharing planned: No
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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.
Sara-Jane Milne, BMR(OT) principal investigator
Winnipeg Health Sciences Centre
Questions about this trial
What is this clinical trial studying?
A study testing Pressure garment and silicone insert and Pressure garment in people with Burns, run by University of Manitoba.
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 6 inclusion and 5 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: withdrawn, as of the sponsor's last update on 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar pliability measured in gm/mm squared (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03159182, which also lists 6 linked publications.
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 18 May 2017.