Study of Silicone Material Inserts To Treat Burn Scars

NCT03159182 | Withdrawn

• 1 other identifier: B2008:056
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Burns

Keywords

Hypertrophic scarring; Silicone Material; Pressure garments

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Scar vascularity

  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 Outcomes (5)

• Scar height

  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.

• Scar itch

  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.

• Scar Appearance

  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.

Study Arms (2)

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.

Device: Pressure garment and silicone insert

Pressure Garment

ACTIVE COMPARATOR

Custom measured pressure garment, to be worn 23 hours per day.

Device: Pressure garment

Interventions

Pressure garment and silicone insert DEVICE

Custom made fabric pressure garment with textile bonded silicone insert on either proximal or distal portion of pressure garment.

Pressure garment and silicone insert

Pressure garment DEVICE

Custom made fabric pressure garment

Pressure Garment

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• Health Sciences Centre Foundation, Manitoba: collaborator

Related Publications (6)

• 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.

  PMID: 8537427 BACKGROUND

• 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.

  PMID: 2529659 RESULT

• 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.

  PMID: 18182896 RESULT

• 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.

  RESULT

• 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.

  PMID: 3220875 RESULT

• 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.

  PMID: 1003586 RESULT

MeSH Terms

Conditions

Burns; Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Wounds and Injuries; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sara-Jane Milne, BMR(OT)

  Winnipeg Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Occupational Therapist

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 18, 2017
• Study Start: September 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: March 1, 2020
• Last Updated: May 18, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share