Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT03159182

Study of Silicone Material Inserts To Treat Burn Scars

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

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
University of Manitoba · Academic / Other
Sex
All
Age
16 Years – 60 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEPressure garment and silicone insertCustom made fabric pressure garment with textile bonded silicone insert on either proximal or distal portion of pressure garment.
DEVICEPressure garmentCustom made fabric pressure garment

Timeline

Start date
2018-09-01
Primary completion
2019-09-01
Completion
2020-03-01
First posted
2017-05-18
Last updated
2017-05-18

Source: ClinicalTrials.gov record NCT03159182. Inclusion in this directory is not an endorsement.