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This study will look at whether ELECT, a new adhesive foam dressing, can offer an alternative to traditional wound care methods.
Patients will be treated with ELECT for 14 days. Data relating to wound healing, the performance of the dressing and the opinion of the doctor will be collected.
The hypothesis of this study is that the ELECT foam adhesive dressing is 'fit for purpose' and will be effective at treating a variety of wounds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ELECT | Experimental | Adhesive Foam Dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELECT | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound progression, (percentage change in area) using a wound imaging measurement and wound documentation system | using a wound imaging, measurement and wound documentation system | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in wound depth | 14 days | |
| Percentage change in wound volume | 14 days | |
| Duration of dressing wear |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Herbert B Slade, MD | Smith & Nephew, Inc. | Study Chair |
| Jaime E Dickerson, PhD | Smith & Nephew, Inc. | Study Director |
| Alessandro Andreone, MD | Inkosi Albert Luthuli Central Hospital (IALCH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inkosi Albert Luthuli Central Hospital (IALCH) | Durban | 4058 | South Africa |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D002056 | Burns |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
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| 14 days |
| The proportion of wounds that have 100% healed or closed by secondary intention. | 14 days |
| Assessment of exudate type and amount | Assessment using a modified Bates-Jensen Would Assessment Tool1 and T.I.M.E.2,3) | 14 days |
| Assessment of Condition of the peri-wound skin | Assessment using a modified Bates-Jensen Would Assessment Tool1 and T.I.M.E.2,3) | 14 days |
| Assessment of the amount of tissue and skin colour | Assessment using a modified Bates-Jensen Would Assessment Tool1 and T.I.M.E.2,3) | 14 days |
| Assessment of infection/clinical signs of infection | Assessment using Normal Clinical practice | 14 days |
| Pain on application and removal of dressing (using a Visual Analogue Scale (VAS) or FLACC scale) | 14 days |
| Reason for dressing change | 14 days |
| Ease of application and removal of the ELECT dressing using the visual analogue scale | 14 days |
| Overall clinician acceptability with the new dressing | Measured using a questionnaire | 14 days |
| Clinician acceptability with dressing performance parameters | Measured using a questionnaire | 14 days |
| Safety in use - all adverse events that occur during the study will be recorded | 14 days |
| D001982 |
| Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |