Wounds
Conditions
Brief summary
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.
Detailed description
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.
Interventions
1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing.
Sponsors
Northwestern University
Halyard Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Males or non-pregnant females aged 21-85 years. Female subjects of child bearing potential must be using method(s) of contraception acceptable to the Investigator and agree to do so from at least the screening visit until one month after administration of the final study dressing. * Subject is willing to undergo the creation of twelve experimental donor sites 1.0 x 1.0 in size with a depth between 0.0012-0.0018 taken from the abdomen per a modification of the Northwestern Abdominoplasty Scar Model * Subjects who are medically acceptable candidates for abdominoplasty (BMI approximately 25-35 kg/m2) as determined by per-study laboratory assessment and clinical evaluation. * Willingness to provide informed consent and to comply with the requirements of this protocol for the full duration of the study.
Exclusion criteria
* Subjects who have received treatment with systemic steroids during the 30 days prior to study enrollment. * Subjects who have received immunosuppressive drugs, radiation or chemotherapy during the three months prior to study enrollment. * Subjects with a history of malignancy in the previous three years. * Subjects with uncontrolled diabetes (A1C \> 8%). * Subjects who are current smokers or have any significant pack-year history of smoking (\>1 pack-year). * Subjects with diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety, tolerability or efficacy. * Subjects who have previously had skin grafts harvested from the area to be studied. * Subjects with a skin disorder (other than chronic venous ulcers) that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial. * Subjects with extensive severe striae that would make it difficult to perform a skin graft on the abdomen and/or evaluate the final scar appearance. * Subjects with a history of clinical significant hypersensitivity to any of the surgical dressings to be used in this trial. * Subjects who are taking, or have taken any Investigational drugs within 3 months prior to the screening visit. * Subjects who are participating in other research Investigations. * Subjects requiring treatment with medications(s) that are known to interfere with wound healing. * Subjects who are or who become pregnant up to and including Day 0 or who are lactating. * Subjects who, in the opinion of the Investigator, are not likely to complete the trial for whatever reason, including significant comorbidities that may adversely affect survival or ability to attend follow up visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing in Days. | 14 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Degree of Epithelialization Percent Change by Digital Photography at Each Time Point Post Wounding. | Day 14 | Wound degree of epithelialization percent change by digital photography at day 14. |
| Pain on Test Versus Control Side Using a Wong-Baker Scale. | Day 14 | 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. |
| Scar Quality Analysis; Modified Vancouver Scar Scale (MVS) | Day 42 | 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). |
| Biopsy & Histology of Wounds. | Day 28 | 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. |
| Scar Quality Analysis; Elastometer | Day 42 | 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. |
| Scar Quality Analysis; Colorimeter | Day 42 | 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. |
| Scar Quality Analysis; Visual Analogue Scale | Day 42 | 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). |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| 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. | 32 |
| Standard Tegaderm Dressing Standard Tegaderm Dressing will be applied. | 8 |
| Standard Tegaderm Dressing Standard Tegaderm Dressing will be applied. | 32 |
| Total | 80 |
Baseline characteristics
| Characteristic | OxyGenesys Dissolved Oxygen Dressing | Total | Standard Tegaderm Dressing |
|---|---|---|---|
| Age, Continuous | 41.6 years STANDARD_DEVIATION 12 | 41.6 years STANDARD_DEVIATION 12 | 41.6 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 wounds | 32 wounds | 16 wounds |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 wounds | 32 wounds | 16 wounds |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 wounds | 0 wounds | 0 wounds |
| Race (NIH/OMB) American Indian or Alaska Native | 0 wounds | 0 wounds | 0 wounds |
| Race (NIH/OMB) Asian | 0 wounds | 0 wounds | 0 wounds |
| Race (NIH/OMB) Black or African American | 8 wounds | 16 wounds | 8 wounds |
| Race (NIH/OMB) More than one race | 0 wounds | 0 wounds | 0 wounds |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 wounds | 0 wounds | 0 wounds |
| Race (NIH/OMB) Unknown or Not Reported | 0 wounds | 0 wounds | 0 wounds |
| Race (NIH/OMB) White | 24 wounds | 48 wounds | 24 wounds |
| Region of Enrollment United States | 8 participants | 8 participants | 8 participants |
| Sex: Female, Male Female | 32 wounds | 64 wounds | 32 wounds |
| Sex: Female, Male Male | 0 wounds | 0 wounds | 0 wounds |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 3 / 8 | 3 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
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.
Time frame: 14 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OxyGenesys Dissolved Oxygen Dressing | Healing in Days. | 13.1 days | Standard Deviation 2.8 |
| Standard Tegaderm Dressing | Healing in Days. | 12.5 days | Standard Deviation 2.1 |
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.
Time frame: Day 28
Population: 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.
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.
Time frame: Day 14
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OxyGenesys Dissolved Oxygen Dressing | Pain on Test Versus Control Side Using a Wong-Baker Scale. | 0.7 units on a scale | Standard Deviation 1.2 |
| Standard Tegaderm Dressing | Pain on Test Versus Control Side Using a Wong-Baker Scale. | 0.7 units on a scale | Standard Deviation 1.2 |
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.
Time frame: Day 42
Population: Data were not collected.
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.
Time frame: Day 42
Population: Data were not collected.
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).
Time frame: Day 42
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OxyGenesys Dissolved Oxygen Dressing | Scar Quality Analysis; Modified Vancouver Scar Scale (MVS) | 3.8 units on a scale | Standard Deviation 1.7 |
| Standard Tegaderm Dressing | Scar Quality Analysis; Modified Vancouver Scar Scale (MVS) | 3.8 units on a scale | Standard Deviation 1.4 |
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).
Time frame: Day 42
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OxyGenesys Dissolved Oxygen Dressing | Scar Quality Analysis; Visual Analogue Scale | 5.8 units on a scale | Standard Deviation 2 |
| Standard Tegaderm Dressing | Scar Quality Analysis; Visual Analogue Scale | 5.9 units on a scale | Standard Deviation 2.2 |
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.
Time frame: Day 14
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OxyGenesys Dissolved Oxygen Dressing | Wound Degree of Epithelialization Percent Change by Digital Photography at Each Time Point Post Wounding. | 81.4 percentage of epithelialization | Standard Deviation 15.7 |
| Standard Tegaderm Dressing | Wound Degree of Epithelialization Percent Change by Digital Photography at Each Time Point Post Wounding. | 91.3 percentage of epithelialization | Standard Deviation 8.3 |