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| ID | Type | Description | Link |
|---|---|---|---|
| I.2007.128 | Other Identifier | BAMC IRB |
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| Name | Class |
|---|---|
| Samueli Institute for Information Biology | OTHER |
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This single-center, prospective, randomized, and controlled study evaluated the efficacy of silver-coated dressing with active microcurrent in comparison to silver-coated dressing with sham microcurrent on wound-closure time for autogenous skin donor sites.
The specific aims of the study are to evaluate the impact of active versus sham direct microcurrent application to silver nylon dressings in the treatment of donor sites for partial thickness thermal injuries. The primary endpoint is wound-closure time (re-epithelialization of 90% or more of wound surface). A secondary endpoint was infection. Exploratory assessments of clinical outcomes, including inflammation, and pain medication (type, dosage, route, timing) will also be conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microcurrent Stimulator + Silverlon | Active Comparator | Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing. Intervention is active electrical stimulation via microcurrent stimulator. |
|
| Silverlon alone | Sham Comparator | Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microcurrent stimulator | Device | Microcurrent stimulation from 15-50 microamps |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Wound Healing | Time to 90% confluent reepitheliazation of donor site, as indicator of wound healing | 20 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leopoldo C Cancio, MD | United States Army Institute of Surgical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USAISR | Fort Sam Houston | Texas | 78234 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16580688 | Background | Kauvar DS, Cancio LC, Wolf SE, Wade CE, Holcomb JB. Comparison of combat and non-combat burns from ongoing U.S. military operations. J Surg Res. 2006 May 15;132(2):195-200. doi: 10.1016/j.jss.2006.02.043. Epub 2006 Mar 31. | |
| 23903090 | Derived | Malin EW, Galin CM, Lairet KF, Huzar TF, Williams JF, Renz EM, Wolf SE, Cancio LC. Silver-coated nylon dressing plus active DC microcurrent for healing of autogenous skin donor sites. Ann Plast Surg. 2013 Nov;71(5):481-4. doi: 10.1097/SAP.0b013e31829d2311. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Microcurrent Stimulator + Silverlon | Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing. Intervention is active electrical stimulation via microcurrent stimulator. Microcurrent stimulator: Microcurrent stimulation from 15-50 microamps Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients |
| FG001 | Silverlon Alone | Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation) Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Microcurrent Stimulator + Silverlon | Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing. Intervention is active electrical stimulation via microcurrent stimulator. Microcurrent stimulator: Microcurrent stimulation from 15-50 microamps Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients |
| 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 | Time to Wound Healing | Time to 90% confluent reepitheliazation of donor site, as indicator of wound healing | Posted | Mean | Full Range | days | 20 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 | Microcurrent Stimulator + Silverlon | Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing. Intervention is active electrical stimulation via microcurrent stimulator. Microcurrent stimulator: Microcurrent stimulation from 15-50 microamps Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | IRB found not to be attributable to study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leopoldo C. Cancio, COL, MC | USAISR | 210-916-3301 | leopoldo.c.cancio.mil@mail.mil |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Silverlon Wound Contact Dressing | Device | Silver coated nylon dressing FDA approved for use on donor sites in burn patients |
|
| BG001 | Silverlon Alone | Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation) Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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|
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| 1 |
| 14 |
| 0 |
| 14 |
| EG001 | Silverlon Alone | Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation) Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients | 1 | 11 | 0 | 11 |
|
| Deep Vein Thrombosis (DVT) | Vascular disorders | Systematic Assessment | Institutional Review Board (IRB) found not to be attributable to study. |
|
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