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| Name | Class |
|---|---|
| Northwestern University | OTHER |
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Twelve acute wounds (6 on either side of the umbilicus) will be surgically created in the lower abdominal area. One side of the umbilicus will be randomized to Oxygenesys treatment arm and the other side will be receiving a standard Tegaderm treatment arm. Time to wound healing will be observed over 14 days.
At least 12 study visits will occur over a 3 month timeframe. Twelve acute wounds (6 on either side of the umbilicus) will be surgically created in the lower abdominal area. One side of the umbilicus will be randomized to Oxygenesys treatment arm and the other side will be receiving a standard Tegaderm treatment arm. Time to wound healing will be observed over 14 days (follow up assessments include wound photography, pain scores, wound biopsies, exudate collection, gene expression and proteomic analysis, scar assessment and adverse event collections. Study visits will occur at:
Prescreening Visit; Day of wounding; Day 2; Day 7; Day 8-14 (until all wounds have healed); Day 28; Day 42; Abdominoplasty Surgery. An abdominoplasty will occur after day 42.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OxyGenesys Dissolved Oxygen Dressing | Experimental | OxyGenesys Dissolved Oxygen Dressing will be applied. |
|
| Standard Tegaderm Dressing | No Intervention | Tegaderm will be applied. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OxyGenesys Dissolved Oxygen Dressing | Device | 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Healing in Days. | Wound healing will be defined as 90% re-epithelialization. Mean time to healing will be compared between the OxyGenesys treated sites and the control treated sites. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Degree of Epithelialization Percent Change by Digital Photography at Each Time Point Post Wounding. | Wound degree of epithelialization percent change by digital photography at day 14. | Day 14 |
| Pain on Test Versus Control Side Using a Wong-Baker Scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Galiano, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
Each participant was assigned to both study groups (acted as her own control), as four wounds on one side of each participant were treated with OxyGenesys dressing, and four wounds on the opposite side of each participant were treated with the Tegaderm control dressing.
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| ID | Title | Description |
|---|---|---|
| FG000 | OxyGenesys Dissolved Oxygen Dressing | OxyGenesys Dissolved Oxygen Dressing will be applied. OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing. |
| FG001 | Standard Tegaderm Dressing | Standard Tegaderm Dressing will be applied. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Each participant was assigned to both study groups (acted as her own control), as four wounds on one side of each participant were treated with OxyGenesys dressing, and four wounds on the opposite side of each participant were treated with the Tegaderm control dressing. In some instances, not all of the participants contributed data to outcomes.
| ID | Title | Description |
|---|---|---|
| BG000 | OxyGenesys Dissolved Oxygen Dressing | OxyGenesys Dissolved Oxygen Dressing will be applied. OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing. |
| BG001 | Standard Tegaderm Dressing |
| 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 | Healing in Days. | Wound healing will be defined as 90% re-epithelialization. Mean time to healing will be compared between the OxyGenesys treated sites and the control treated sites. | Each participant was assigned to both study groups (acted as her own control), as four wounds on one side of each participant were treated with OxyGenesys dressing, and four wounds on the opposite side of each participant were treated with the Tegaderm control dressing. | Posted | Mean | Standard Deviation | days | 14 days | wounds | wounds |
|
11 months
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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 | OxyGenesys Dissolved Oxygen Dressing | OxyGenesys Dissolved Oxygen Dressing will be applied. OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| folliculitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Galiano, Associate Professor of Surgery | Northwestern University | 312.695.3908 |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Subjects will report pain level on each side of their abdomen at day 14. The Wong-Baker scale is: 0 points = no hurt, 2 = hurts little bit, 4 = hurts little more, 6 = hurts even more, 8 = hurts whole lot, 10 = hurts worst. A grand mean and standard deviation (reported below) were determined by combining participant scores.The identical group mean and standard deviation values reported below are correct. |
| Day 14 |
| Biopsy & Histology of Wounds. | Biopsies will be taken from all wounds at day 28. Analysis of tissue samples will specifically evaluate differences and rates of collagen deposition, angiogenesis and re-epithelialization between the two study arms. | Day 28 |
| Scar Quality Analysis; Modified Vancouver Scar Scale (MVS) | Scar quality will be assessed and analyzed between the two groups using the Modified Vancouver Scar Scale at day 42. The MVS assessment is the tool that the Investigator will use to evaluate scar pliability (0 points = normal, 1 = supple, 2 = yielding, 3 = firm, 4 = adherent), height (0 = normal, 1 = 1-2 mm, 2 = 3-4 mm, 3 = 5-6 mm, 4 = > 6 mm), vascularity (0 = normal, 1 = pink, 2 = red, 3 = purple), and pigmentation (0 = normal, 1 = slight, 2 = moderately, 3 = severely). An average score for each participant was calculated by combining scores from each subscale. Average participant scores in each study group were combined to produce a grand mean and standard deviation for each group (reported below). | Day 42 |
| Scar Quality Analysis; Visual Analogue Scale | Scar quality of each study participant was assessed by using the Visual Analogue Scale (VAS) at day 42. The VAS is an 11-point scale that ranges from 0 (normal skin) to 10 (worst possible scar). The values on the scale indicate the observer's global impression of the scar (lower numbers are better than higher numbers). | Day 42 |
| Scar Quality Analysis; Elastometer | Scar quality was to be assessed for each study participant using an elastometer at day 42. An elastometer is used to assess scar elasticity. Unfortunately, the data for this study endpoint were not collected properly, and despite our best efforts, there is no way to resolve this issue. Thus, no data can be reported for this study outcome. | Day 42 |
| Scar Quality Analysis; Colorimeter | Scar quality was to be assessed for each study participant using a colorimeter at day 42. A colorimeter was to be used to measure the extent of erythema, and melanin content, of the skin. Unfortunately, the data for this study endpoint were not collected properly, and despite our best efforts, there is no way to resolve this issue. Thus, no data can be reported for this study outcome. | Day 42 |
Standard Tegaderm Dressing will be applied. |
| BG002 | Total | Total of all reporting groups |
| wounds |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Units | wounds | wounds |
|
| Ethnicity (NIH/OMB) | Count of Units | wounds | wounds |
|
| Race (NIH/OMB) | Count of Units | wounds | wounds |
|
| Region of Enrollment | Number | participants | Participants |
|
| Standard Tegaderm Dressing |
Standard Tegaderm Dressing will be applied. |
|
|
| Secondary | Wound Degree of Epithelialization Percent Change by Digital Photography at Each Time Point Post Wounding. | Wound degree of epithelialization percent change by digital photography at day 14. | Each participant was assigned to both study groups (acted as her own control), as four wounds on one side of each participant were treated with OxyGenesys dressing, and four wounds on the opposite side of each participant were treated with the Tegaderm control dressing. | Posted | Mean | Standard Deviation | percentage of epithelialization | Day 14 | wounds | wounds |
|
|
|
| Secondary | Pain on Test Versus Control Side Using a Wong-Baker Scale. | Subjects will report pain level on each side of their abdomen at day 14. The Wong-Baker scale is: 0 points = no hurt, 2 = hurts little bit, 4 = hurts little more, 6 = hurts even more, 8 = hurts whole lot, 10 = hurts worst. A grand mean and standard deviation (reported below) were determined by combining participant scores.The identical group mean and standard deviation values reported below are correct. | Each participant was assigned to both study groups (acted as her own control), as four wounds on one side of each participant were treated with OxyGenesys dressing, and four wounds on the opposite side of each participant were treated with the Tegaderm control dressing. Five participants did not report their day 14 measurements. | Posted | Mean | Standard Deviation | units on a scale | Day 14 | wounds | wounds |
|
|
|
| Secondary | Biopsy & Histology of Wounds. | Biopsies will be taken from all wounds at day 28. Analysis of tissue samples will specifically evaluate differences and rates of collagen deposition, angiogenesis and re-epithelialization between the two study arms. | Each participant was assigned to both study groups (acted as her own control). Samples were collected, but not analyzed because the comparative broad healing endpoints did not provide compelling evidence for tissue processing. No data are presented because the Outcome Measure has zero total participants analyzed. | Posted | Day 28 | wound biopsies | wound biopsies |
|
|
| Secondary | Scar Quality Analysis; Modified Vancouver Scar Scale (MVS) | Scar quality will be assessed and analyzed between the two groups using the Modified Vancouver Scar Scale at day 42. The MVS assessment is the tool that the Investigator will use to evaluate scar pliability (0 points = normal, 1 = supple, 2 = yielding, 3 = firm, 4 = adherent), height (0 = normal, 1 = 1-2 mm, 2 = 3-4 mm, 3 = 5-6 mm, 4 = > 6 mm), vascularity (0 = normal, 1 = pink, 2 = red, 3 = purple), and pigmentation (0 = normal, 1 = slight, 2 = moderately, 3 = severely). An average score for each participant was calculated by combining scores from each subscale. Average participant scores in each study group were combined to produce a grand mean and standard deviation for each group (reported below). | Each participant was assigned to both study groups (acted as her own control), as four wounds on one side of each participant were treated with OxyGenesys dressing, and four wounds on the opposite side of each participant were treated with the Tegaderm control dressing. One participant did not report for her day 42 measurement. | Posted | Mean | Standard Deviation | units on a scale | Day 42 | wounds | wounds |
|
|
|
| Secondary | Scar Quality Analysis; Visual Analogue Scale | Scar quality of each study participant was assessed by using the Visual Analogue Scale (VAS) at day 42. The VAS is an 11-point scale that ranges from 0 (normal skin) to 10 (worst possible scar). The values on the scale indicate the observer's global impression of the scar (lower numbers are better than higher numbers). | Each participant was assigned to both study groups (acted as her own control), as four wounds on one side of each participant were treated with OxyGenesys dressing, and four wounds on the opposite side of each participant were treated with the Tegaderm control dressing. One participant did not report for her day 42 measurement. | Posted | Mean | Standard Deviation | units on a scale | Day 42 | wounds | wounds |
|
|
|
| Secondary | Scar Quality Analysis; Elastometer | Scar quality was to be assessed for each study participant using an elastometer at day 42. An elastometer is used to assess scar elasticity. Unfortunately, the data for this study endpoint were not collected properly, and despite our best efforts, there is no way to resolve this issue. Thus, no data can be reported for this study outcome. | Data were not collected. | Posted | Day 42 |
|
|
| Secondary | Scar Quality Analysis; Colorimeter | Scar quality was to be assessed for each study participant using a colorimeter at day 42. A colorimeter was to be used to measure the extent of erythema, and melanin content, of the skin. Unfortunately, the data for this study endpoint were not collected properly, and despite our best efforts, there is no way to resolve this issue. Thus, no data can be reported for this study outcome. | Data were not collected. | Posted | Day 42 |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 3 |
| 8 |
| EG001 | Standard Tegaderm Dressing | Standard Tegaderm Dressing will be applied. | 0 | 8 | 0 | 8 | 3 | 8 |
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