Study of Silicone Material Inserts To Treat Burn Scars

Burns Clinical Trial

Official title:

Effectiveness of Silicone Material Inserts Within Pressure Garments in the Treatment of Hypertrophic Burn Scars

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03159182
• Other study ID #: B2008:056
• Status: Withdrawn
• Phase: N/A
• First received: May 16, 2017
• Last updated: May 16, 2017
• Start date: September 2018
• Est. completion date: March 2020

Study information

• Verified date: May 2017
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns

Intervention

Device:
• Pressure garment and silicone insert
Custom made fabric pressure garment with textile bonded silicone insert on either proximal or distal portion of pressure garment.
• Pressure garment
Custom made fabric pressure garment

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Health Sciences Centre Foundation, Manitoba

References & Publications (6)

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. — View 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.

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Scar height	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.	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	Scar itch	Scar itch will be measured using a visual analogue scale (VAS).	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	Scar Appearance	Will be measured using a visual analogue scale (VAS).	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	Comfort of garment	Will be measured using ordered response scales.	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	Limitations to movement	Will be measured using ordered response scales.	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.
Primary	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.	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	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.	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.