Trials / Withdrawn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- Withdrawn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
| Type | Name | Description |
|---|---|---|
| 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. |
| DEVICE | Pressure garment | Custom 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.