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A total of 68 adult and pediatric patients who suffer from at least one discrete partial thickness thermal burn wound (Grade II) will be recruited. Subjects will be randomized (1:1) to either PermeaDermĀ® or Mepilex AgĀ®. Evaluations will occur at 7, 14 and 21 days with long term follow-up at 6 and 12 months.
A total of 68 adult and pediatric patients who suffer from at least one discrete partial thickness thermal burn wound (Grade II) will be recruited from the clinical practices of the site Principal Investigators.
Participants and/or the Legally Authorized Representative (LAR) as appropriate will be fully informed regarding the conduct of the clinical trial including all potential risks and benefits.
All Participants must be consented, randomized (1:1) and treated within 72 hours of injury.
It is permissible for a Study Participant to be enrolled if they have more than one burn wound.
If more than one partial thickness burn is treated, the Investigator must indicate prior to randomization which wound is to be considered for primary analysis. This wound will be called the Primary Wound and is to be evaluated by a Blinded Assessor.
Additional partial thickness wounds must be treated with the same product to which the Study Participant was randomized and will be included in secondary analysis. These wounds are to be described as Secondary Wounds and are to be evaluated by the Unblinded Assessor.
Evaluations will occur at 7, 14 and 21 days with long term follow-up at 6 and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PermeaDermĀ® | Experimental | N=34 Participants will receive application of PermeaDermĀ® as outlined in Directions for Use |
|
| Mepilex AgĀ® | Active Comparator | Participants will receive application of Mepilex AgĀ® as outlined in Directions for Use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PermeaDermĀ® | Device | Wound Management Device |
| |
| Mepilex Ag |
| Measure | Description | Time Frame |
|---|---|---|
| Reepithelialization | Time to 100 percent- primary wound | 14 days |
| Alternate therapy | Time to conversion to alternate therapy- primary wound | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Re-epithelialization | Percent reepithelialization primary and secondary Wounds | 14 days |
| Alternate therapy | Time to conversion to alternate therapy- secondary wounds |
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Inclusion Criteria:
Participants will be included if all the following criteria are met.
Exclusion Criteria:
Participants will be excluded if s/he meet any of the following criteria.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miao Yu, Ph.D | Contact | 1-858-753-9530 | miao.yu@stedical.com |
| Name | Affiliation | Role |
|---|---|---|
| David Greenhalgh, M.D. | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis | Recruiting | Sacramento | California | 95817 | United States |
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Prospective, randomized, single-blinded, adaptive, controlled clinical trial.
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It is intended that blinded assessment of wounds will be performed at 14 days after treatment.
| Device |
Wound Dressing |
|
| up to 12 Months |
| Adverse Events | Occurrence, duration, severity, seriousness, expectedness, and relationship of adverse events | 21 days |
| Severity of pain | Wong-Backer Faces pain rating scale and in adults as measured by the Numerical Rating Scale (0-10); | Up to 12 Months |
| Scar characteristics | Patient and Observer Scar Assessment Scale (POSAS) | 6 and 12 months |
| Satisfaction with treatment | Brisbane Burn Scar Impact Profile (BBSIP) | 6 and 12 months |
| Dressing Changes Required | Number | Up to 21 Days |