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| Name | Class |
|---|---|
| Medline Industries | INDUSTRY |
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The purpose of this single center, prospective case series is to evaluate the effective management of split-thickness skin graft donor site wounds using Opticell Ag (Chitosan-based dressing).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opticell Ag | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opticell Ag | Device | Opticell Ag+ applied to STSG donor site |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain | Pain reported by Subject using a visual analog scale (VAS). This scale measures an unidimensional measure of pain intensity by means of a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length. The left side of the scale signifies no pain (score of 0), and the right side the other extreme, worst pain imaginable (score of 10). Patients are asked to place a line perpendicular to the VAS scale at the point that represents their pain intensity. | Assessed up to 14 days of use |
| Wound Healing Rate (Re-epithelialization) | The extent of re-epithelialization was evaluated by the surgeon and a blinded expert using photographs taken on days 10-14 and at 1 month postoperatively. | Assessed up to 1 month postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Healing Quality | Assessed using the Vancouver scar scale (VSS) 1-month post-operatively. The VSS is a widely used scale in clinical practice to document change in scar appearance. The scale scores four parameters: pigmentation, vascularity, pliability, and height for a total of 13 points. Normal appearance in each of the parameters garners a score of 0 and scores get higher (2-3) as an increase in parameters is observed. The lower the score, the better the outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Indranil Sinha, MD | Brigham and Women's Hospital | Principal Investigator |
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Enrolled participants were excluded from the study prior to experimental dressing application if they were found unable to comply with necessary wound care/follow up, or if their surgeon requested they no longer be enrolled.
Patients scheduled to undergo split-thickness skin graft harvesting in the Divisions of Burn and Plastic Surgery at the Brigham and Women's Hospital during the period of time from January to December 2016 were identified as possible study candidates.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Subjects undergoing split-thickness autografting by the burn or plastic surgery services at the Brigham and Women's Hospital.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Pain | Pain reported by Subject using a visual analog scale (VAS). This scale measures an unidimensional measure of pain intensity by means of a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length. The left side of the scale signifies no pain (score of 0), and the right side the other extreme, worst pain imaginable (score of 10). Patients are asked to place a line perpendicular to the VAS scale at the point that represents their pain intensity. | Pain was evaluated on postoperative day 1, before the dressing was changed on days 5-7, and before and after dressing removal on days 10-14 using the Visual Analog Scale (VAS). The patient was asked to mark his/her pain level on the line between the two endpoints. | Posted | Mean | Standard Deviation | units on a scale | Assessed up to 14 days of use |
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Adverse event data was collected from January to December 2016.
Although no adverse effects were expected in this study, any occurrence was reported to the Brigham and Women's Hospital/Harvard Medical School IRB within 5 days while following the Partners Human Research Committee Guidelines for Adverse Event Reporting.
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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 | 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 |
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This pilot study is not a randomized, control study and is limited by the absence of a small sample size and direct comparison group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Indranil Sinha, MD | Brigham and Women's Hospital | 617-732-5282 | isinha@bwh.harvard.edu |
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Opticell Ag dressing applied to STSG donor site
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| Assessed up to 1 month of use |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Allergies to chitosan/shellfish | Count of Participants | Participants |
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| Reason for split-thickness skin graft | Count of Participants | Participants |
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| Donor site area | Mean | Full Range | square centimeters |
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| Dermatome setting | Mean | Full Range | inches |
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| Primary | Wound Healing Rate (Re-epithelialization) | The extent of re-epithelialization was evaluated by the surgeon and a blinded expert using photographs taken on days 10-14 and at 1 month postoperatively. | Posted | Mean | Standard Deviation | percent (%) | Assessed up to 1 month postoperatively. |
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| Secondary | Wound Healing Quality | Assessed using the Vancouver scar scale (VSS) 1-month post-operatively. The VSS is a widely used scale in clinical practice to document change in scar appearance. The scale scores four parameters: pigmentation, vascularity, pliability, and height for a total of 13 points. Normal appearance in each of the parameters garners a score of 0 and scores get higher (2-3) as an increase in parameters is observed. The lower the score, the better the outcome. | Posted | Mean | Standard Deviation | units on a scale | Assessed up to 1 month of use |
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