OxyGenesys Dissolved Oxygen Dressing; Abdominoplasty at Northwestern University

• Sponsor: Halyard Health (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02591537
• Collaborator: Northwestern University (Other)
• Enrollment: 8
• Location: 1
• Arms: 2
• Actual Duration (Months): 11
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Wounds	Device: OxyGenesys Dissolved Oxygen Dressing	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Prospective, Randomized, Single Center, Controlled Evaluation of the Effectiveness of OxyGenesys Topical Dissolved Oxygen Dressing in Accelerating the Healing of Split Thickness Skin Graft Donor Sites Using the NWU Abdominoplasty Scar Model
• Actual Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OxyGenesys Dissolved Oxygen Dressing OxyGenesys Dissolved Oxygen Dressing will be applied.	Device: OxyGenesys Dissolved Oxygen Dressing; 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing.
No Intervention: Standard Tegaderm Dressing Tegaderm will be applied.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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).

5. 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).

6. 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.

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Feinberg School of Medicine	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Halyard Health
• Northwestern University

Investigators

• Principal Investigator: Robert Galiano, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Halyard Health
• ClinicalTrials.gov Identifier: NCT02591537
• Other Study ID Numbers: 100-15-0001
• First Posted: Oct 29, 2015
• Last Update Posted: Oct 4, 2017
• Last Verified: Aug 1, 2017

Study Results

Participant Flow

Pre-assignment Detail	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/Group Title	OxyGenesys Dissolved Oxygen Dressing	Standard Tegaderm Dressing
Arm/Group Description	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 will be applied.
Period Title: Overall Study
STARTED	8	8
COMPLETED	8	8
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	OxyGenesys Dissolved Oxygen Dressing	Standard Tegaderm Dressing	Total
Arm/Group Description	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 will be applied.	Total of all reporting groups
Overall Participants	8	8	8
Overall wounds	32	32	64
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.6 (12)	41.6 (12)	41.6 (12)
Sex: Female, Male (wounds) [Count of Units]
Female	32	32	64
Male	0	0	0
Ethnicity (NIH/OMB) (wounds) [Count of Units]
Hispanic or Latino	16	16	32
Not Hispanic or Latino	16	16	32
Unknown or Not Reported	0	0	0
Race (NIH/OMB) (wounds) [Count of Units]
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) [Number]
United States	8 100%	8 100%	8 100%

Outcome Measures

1. Primary Outcome

Title	Healing in Days.
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	OxyGenesys Dissolved Oxygen Dressing	Standard Tegaderm Dressing
Arm/Group Description	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 will be applied.
Measure Participants	8	8
Measure wounds	32	32
Mean (Standard Deviation) [days]	13.1 (2.8)	12.5 (2.1)

2. Secondary Outcome

Title	Wound Degree of Epithelialization Percent Change by Digital Photography at Each Time Point Post Wounding.
Description	Wound degree of epithelialization percent change by digital photography at day 14.
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

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/Group Title	OxyGenesys Dissolved Oxygen Dressing	Standard Tegaderm Dressing
Arm/Group Description	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 will be applied.
Measure Participants	8	8
Measure wounds	32	32
Mean (Standard Deviation) [percentage of epithelialization]	81.4 (15.7)	91.3 (8.3)

3. Secondary Outcome

Title	Pain on Test Versus Control Side Using a Wong-Baker Scale.
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	OxyGenesys Dissolved Oxygen Dressing	Standard Tegaderm Dressing
Arm/Group Description	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 will be applied.
Measure Participants	3	3
Measure wounds	12	12
Mean (Standard Deviation) [units on a scale]	0.7 (1.2)	0.7 (1.2)

4. Secondary Outcome

Title	Biopsy & Histology of Wounds.
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	OxyGenesys Dissolved Oxygen Dressing	Standard Tegaderm Dressing
Arm/Group Description	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 will be applied.
Measure Participants	0	0
Measure wound biopsies	0	0

5. Secondary Outcome

Title	Scar Quality Analysis; Modified Vancouver Scar Scale (MVS)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	OxyGenesys Dissolved Oxygen Dressing	Standard Tegaderm Dressing
Arm/Group Description	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 will be applied.
Measure Participants	7	7
Measure wounds	28	28
Mean (Standard Deviation) [units on a scale]	3.8 (1.7)	3.8 (1.4)

6. Secondary Outcome

Title	Scar Quality Analysis; Visual Analogue Scale
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	OxyGenesys Dissolved Oxygen Dressing	Standard Tegaderm Dressing
Arm/Group Description	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 Dresssing will be applied.
Measure Participants	7	7
Measure wounds	28	28
Mean (Standard Deviation) [units on a scale]	5.8 (2)	5.9 (2.2)

7. Secondary Outcome

Title	Scar Quality Analysis; Elastometer
Description	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

Outcome Measure Data

Analysis Population Description

Data were not collected.

Arm/Group Title	OxyGenesys Dissolved Oxygen Dressing	Standard Tegaderm Dressing
Arm/Group Description	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 will be applied.
Measure Participants	0	0

8. Secondary Outcome

Title	Scar Quality Analysis; Colorimeter
Description	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

Outcome Measure Data

Analysis Population Description

Data were not collected.

Arm/Group Title	OxyGenesys Dissolved Oxygen Dressing	Standard Tegaderm Dressing
Arm/Group Description	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 will be applied.
Measure Participants	0	0

Adverse Events

Time Frame	11 months
Arm/Group Title	OxyGenesys Dissolved Oxygen Dressing		Standard Tegaderm Dressing
Arm/Group Description	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 will be applied.
All Cause Mortality
	OxyGenesys Dissolved Oxygen Dressing		Standard Tegaderm Dressing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)
Serious Adverse Events
	OxyGenesys Dissolved Oxygen Dressing		Standard Tegaderm Dressing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	OxyGenesys Dissolved Oxygen Dressing		Standard Tegaderm Dressing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/8 (37.5%)		3/8 (37.5%)
Skin and subcutaneous tissue disorders
folliculitis	3/8 (37.5%)	3	3/8 (37.5%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.