Study of Silicone Material Inserts To Treat Burn Scars

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-30

Study Completion Date

2020-03-31

Brief Summary

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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.

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Detailed Description

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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

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pressure garment and silicone insert

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.

Group Type EXPERIMENTAL

Pressure garment and silicone insert

Intervention Type DEVICE

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

Pressure Garment

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

Group Type ACTIVE_COMPARATOR

Pressure garment

Intervention Type DEVICE

Custom made fabric pressure garment

Interventions

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Pressure garment and silicone insert

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

Intervention Type DEVICE

Pressure garment

Custom made fabric pressure garment

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No