An interventional study of OxyGenesys Dissolved Oxygen Dressing in Wounds, sponsored by Halyard Health. Completed at 1 site in United States. Open to participants aged 21 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-04.
Sponsored by Halyard Health · Not applicable, Interventional, and Treatment
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.
5,085 studies on the registry are indexed under Wounds and Injuries; 849 are open to participants now.
This study's enrollment of 8 is below the median of 52 across 3,261 interventional studies indexed under Wounds and Injuries.
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Exclusion Criteria:
OxyGenesys Dissolved Oxygen Dressing will be applied.
Device: OxyGenesys Dissolved Oxygen Dressing
Tegaderm will be applied.
1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing.
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
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
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
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
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
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
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
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
| Milestone | OxyGenesys Dissolved Oxygen Dressing | Standard Tegaderm Dressing |
|---|---|---|
| Started | 8 | 8 |
| Completed | 8 | 8 |
| Not completed | 0 | 0 |
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.
| days | OxyGenesys Dissolved Oxygen Dressing | Standard Tegaderm Dressing |
|---|---|---|
| Healing in Days. | 13.1 ± 2.8 | 12.5 ± 2.1 |
Wound degree of epithelialization percent change by digital photography at day 14.
| percentage of epithelialization | OxyGenesys Dissolved Oxygen Dressing | Standard Tegaderm Dressing |
|---|---|---|
| Wound Degree of Epithelialization Percent Change by Digital Photography at Each Time Point Post Wounding. | 81.4 ± 15.7 | 91.3 ± 8.3 |
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.
| units on a scale | OxyGenesys Dissolved Oxygen Dressing | Standard Tegaderm Dressing |
|---|---|---|
| Pain on Test Versus Control Side Using a Wong-Baker Scale. | 0.7 ± 1.2 | 0.7 ± 1.2 |
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.
No measurements were reported for this outcome.
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).
| units on a scale | OxyGenesys Dissolved Oxygen Dressing | Standard Tegaderm Dressing |
|---|---|---|
| Scar Quality Analysis; Modified Vancouver Scar Scale (MVS) | 3.8 ± 1.7 | 3.8 ± 1.4 |
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).
| units on a scale | OxyGenesys Dissolved Oxygen Dressing | Standard Tegaderm Dressing |
|---|---|---|
| Scar Quality Analysis; Visual Analogue Scale | 5.8 ± 2 | 5.9 ± 2.2 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over 11 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OxyGenesys Dissolved Oxygen Dressing | 0/8 (0%) | 0/8 (0%) | 3/8 (37.5%) |
| Standard Tegaderm Dressing | 0/8 (0%) | 0/8 (0%) | 3/8 (37.5%) |
| Event | OxyGenesys Dissolved Oxygen Dressing | Standard Tegaderm Dressing |
|---|---|---|
| folliculitisSkin and subcutaneous tissue disorders | 3/8 | 3/8 |
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.
| Age, Continuous(years) | OxyGenesys Dissolved Oxygen Dressing | Standard Tegaderm Dressing | Total |
|---|---|---|---|
| Mean | 41.6 ± 12 | 41.6 ± 12 | 41.6 ± 12 |
| Sex: Female, Male(wounds) | OxyGenesys Dissolved Oxygen Dressing | Standard Tegaderm Dressing | Total |
|---|---|---|---|
| Female | 32 | 32 | 64 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(wounds) | OxyGenesys Dissolved Oxygen Dressing | Standard Tegaderm Dressing | Total |
|---|---|---|---|
| Hispanic or Latino | 16 | 16 | 32 |
| Not Hispanic or Latino | 16 | 16 | 32 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(wounds) | OxyGenesys Dissolved Oxygen Dressing | Standard Tegaderm Dressing | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 8 | 8 | 16 |
| White | 24 | 24 | 48 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | OxyGenesys Dissolved Oxygen Dressing | Standard Tegaderm Dressing | Total |
|---|---|---|---|
| United States | 8 | 8 | 8 |
Ran from Oct 2015 to primary completion in Sep 2016, 11 months.
Results were first posted in Oct 2017, 1 year 1 month after primary completion.
Of 105 industry-sponsored interventional studies with no phase under Wounds and Injuries, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 29. This study's 11 months is below that.
Counting every sponsor, half of 1,394 studies reached it within 21 months; a quarter within 9 and three quarters within 43.
Wounds and Injuries covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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