Trial Outcomes & Findings for OxyGenesys Dissolved Oxygen Dressing; Abdominoplasty at Northwestern University (NCT NCT02591537)

Last Updated: 2017-10-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

14 days

Results posted on

2017-10-04

Participant Flow

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.

Unit of analysis: wounds

Participant milestones

Participant milestones
Measure	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.	Standard Tegaderm Dressing Standard Tegaderm Dressing will be applied.
Overall Study STARTED	8 32	8 32
Overall Study COMPLETED	8 32	8 32
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

OxyGenesys Dissolved Oxygen Dressing; Abdominoplasty at Northwestern University

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OxyGenesys Dissolved Oxygen Dressing n=32 wounds OxyGenesys Dissolved Oxygen Dressing will be applied. OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing.	Standard Tegaderm Dressing n=32 wounds Standard Tegaderm Dressing will be applied.	Total n=64 wounds Total of all reporting groups
Age, Continuous	41.6 years STANDARD_DEVIATION 12 • n=5 Participants	41.6 years STANDARD_DEVIATION 12 • n=7 Participants	41.6 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	32 wounds n=32 wounds	32 wounds n=32 wounds	64 wounds n=64 wounds
Sex: Female, Male Male	0 wounds n=32 wounds	0 wounds n=32 wounds	0 wounds n=64 wounds
Ethnicity (NIH/OMB) Hispanic or Latino	16 wounds n=32 wounds	16 wounds n=32 wounds	32 wounds n=64 wounds
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 wounds n=32 wounds	16 wounds n=32 wounds	32 wounds n=64 wounds
Ethnicity (NIH/OMB) Unknown or Not Reported	0 wounds n=32 wounds	0 wounds n=32 wounds	0 wounds n=64 wounds
Race (NIH/OMB) American Indian or Alaska Native	0 wounds n=32 wounds	0 wounds n=32 wounds	0 wounds n=64 wounds
Race (NIH/OMB) Asian	0 wounds n=32 wounds	0 wounds n=32 wounds	0 wounds n=64 wounds
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 wounds n=32 wounds	0 wounds n=32 wounds	0 wounds n=64 wounds
Race (NIH/OMB) Black or African American	8 wounds n=32 wounds	8 wounds n=32 wounds	16 wounds n=64 wounds
Race (NIH/OMB) White	24 wounds n=32 wounds	24 wounds n=32 wounds	48 wounds n=64 wounds
Race (NIH/OMB) More than one race	0 wounds n=32 wounds	0 wounds n=32 wounds	0 wounds n=64 wounds
Race (NIH/OMB) Unknown or Not Reported	0 wounds n=32 wounds	0 wounds n=32 wounds	0 wounds n=64 wounds
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	OxyGenesys Dissolved Oxygen Dressing n=8 Participants OxyGenesys Dissolved Oxygen Dressing will be applied. OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing.	Standard Tegaderm Dressing n=8 Participants Standard Tegaderm Dressing will be applied.
Healing in Days.	13.1 days Standard Deviation 2.8	12.5 days Standard Deviation 2.1

SECONDARY outcome

Timeframe: Day 14

Wound degree of epithelialization percent change by digital photography at day 14.

Outcome measures

Outcome measures
Measure	OxyGenesys Dissolved Oxygen Dressing n=32 wounds OxyGenesys Dissolved Oxygen Dressing will be applied. OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing.	Standard Tegaderm Dressing n=32 wounds Standard Tegaderm Dressing will be applied.
Wound Degree of Epithelialization Percent Change by Digital Photography at Each Time Point Post Wounding.	81.4 percentage of epithelialization Standard Deviation 15.7	91.3 percentage of epithelialization Standard Deviation 8.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	OxyGenesys Dissolved Oxygen Dressing n=12 wounds OxyGenesys Dissolved Oxygen Dressing will be applied. OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing.	Standard Tegaderm Dressing n=12 wounds Standard Tegaderm Dressing will be applied.
Pain on Test Versus Control Side Using a Wong-Baker Scale.	0.7 units on a scale Standard Deviation 1.2	0.7 units on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	OxyGenesys Dissolved Oxygen Dressing n=28 wounds OxyGenesys Dissolved Oxygen Dressing will be applied. OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing.	Standard Tegaderm Dressing n=28 wounds Standard Tegaderm Dressing will be applied.
Scar Quality Analysis; Modified Vancouver Scar Scale (MVS)	3.8 units on a scale Standard Deviation 1.7	3.8 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	OxyGenesys Dissolved Oxygen Dressing n=28 wounds OxyGenesys Dissolved Oxygen Dressing will be applied. OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing.	Standard Tegaderm Dressing n=28 wounds Standard Tegaderm Dressing will be applied.
Scar Quality Analysis; Visual Analogue Scale	5.8 units on a scale Standard Deviation 2	5.9 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: Day 42

Population: Data were not collected.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 42

Population: Data were not collected.

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.

Outcome measures

Outcome data not reported

Adverse Events

OxyGenesys Dissolved Oxygen Dressing

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Standard Tegaderm Dressing

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	OxyGenesys Dissolved Oxygen Dressing n=8 participants at risk OxyGenesys Dissolved Oxygen Dressing will be applied. OxyGenesys Dissolved Oxygen Dressing: 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing.	Standard Tegaderm Dressing n=8 participants at risk Standard Tegaderm Dressing will be applied.
Skin and subcutaneous tissue disorders folliculitis	37.5% 3/8 • Number of events 3 • 11 months	37.5% 3/8 • Number of events 3 • 11 months

Additional Information

Dr. Robert Galiano, Associate Professor of Surgery

Northwestern University

Phone: 312.695.3908

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place