Evaluation of Opticell Ag on Split-Thickness Skin Graft Donor Sites in Adult Subjects
NCT ID: NCT02642679
Last Updated: 2017-12-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2016-01-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Opticell Ag
Opticell Ag covered with a transparent occlusive dressing (Tegaderm) with evenly distributed perforations which permit a controlled leakage into a layer of cotton gauze pads placed directly over the Opticell Ag and occlusive dressing combination.
Opticell Ag
Opticell Ag+ applied to STSG donor site
Interventions
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Opticell Ag
Opticell Ag+ applied to STSG donor site
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject must be receiving a split-thickness skin graft (STSG)
* Wounds must not exceed 10% total body surface area (TBSA)
* Any donor site
* Ability to comply with necessary wound care/follow up
Exclusion Criteria
* Subject has been diagnosed with Diabetes
* Subject is a smoker
* Subject takes steroids
* Subject is sensitive and/or allergic to shellfish and/or silver
* Wounds that exceed 10% total body surface area (TBSA)
* Inability to comply with necessary wound care/follow up
18 Years
ALL
No
Sponsors
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Medline Industries
INDUSTRY
Brigham and Women's Hospital
OTHER
Responsible Party
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Indranil Sinha
Assistant Professor of Surgery, Harvard Medical School, Division of Plastic Surgery
Principal Investigators
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Indranil Sinha, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Other Identifiers
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2015P001975
Identifier Type: -
Identifier Source: org_study_id
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