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Approximately 55-65 subjects from 3-6 sites suffering from a burn injury covering 1-25% Total Body Surface Area (TBSA) will be evaluated providing they fulfill all inclusion and none of the exclusion criteria and have given a signed and dated informed consent. Study site will be from 1-15%. Each subject will be followed once a week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. All dressing changes will be performed at the clinic and gauze rolls will be used as secondary dressing. All dressing changes will be registered in a dressing log. All subjects will be consecutively allocated to a subject code.
see Brief summary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepitel Ag | Experimental | Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepitel Ag | Device | Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Healed at Day 14. | > = 95 % epitheliazation | Healing will be assessed after 14 days. |
| Proportion of Subjects Healed at Day 21. | The proportion of subjects healed will be assessed at day 14. Wounds not healed at day 14 will be assessed again at day 21. | Healing will be assessed after 21 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Study Burn Healed. | Percent of study burn healed measured by PictZar photo analysis of tissue types. | At day 21 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Silverstein, MD | INTEGRIS Baptist Medical Center, Inc. Paul Silverstein Burn Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Burn Center | Phoenix | Arizona | 85008 | United States | ||
| Orlando Regional Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mepitel Ag | Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues. Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mepitel Ag | Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues. Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Healed at Day 14. | > = 95 % epitheliazation | Number | participants | Healing will be assessed after 14 days. |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mepitel Ag | Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues. Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased pain | Skin and subcutaneous tissue disorders | Non-systematic Assessment | # Increased burn pain, subject was seen one day early at the burn clinic. The study site was at that time healed. All burns were treated with Mepitel Ag. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joan Wilson | Molnlycke Health Care AB | 706 504 8997 | joan.wilson@molnlycke.com |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Orlando |
| Florida |
| 32806 |
| United States |
| Wishard | Indianapolis | Indiana | 46202 | United States |
| Paul Silverstein, MD | Oklahoma City | Oklahoma | 73116 | United States |
| S:t Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Proportion of Subjects Healed at Day 21. | The proportion of subjects healed will be assessed at day 14. Wounds not healed at day 14 will be assessed again at day 21. | Number | participants | Healing will be assessed after 21 days. |
|
|
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| Secondary | Percent of Study Burn Healed. | Percent of study burn healed measured by PictZar photo analysis of tissue types. | Median | Full Range | percentage of healing | At day 21 |
|
|
|
| 0 |
| 45 |
| 3 |
| 45 |
|
| Suspected cellulitis | Infections and infestations | Non-systematic Assessment | # Suspected cellulitis |
|
| Increased pain | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Increased pain to RUE (right upper extremity), withdrawn from the investigation |
|
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