OxyGenesys Dissolved Oxygen Dressing; Abdominoplasty at Northwestern University

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Wounds

Intervention / Treatment
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* Device: OxyGenesys Dissolved Oxygen Dressing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OxyGenesys Dissolved Oxygen Dressing<br>OxyGenesys Dissolved Oxygen Dressing will be applied. | Device: OxyGenesys Dissolved Oxygen Dressing<br>* 1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing.<br>|
| No Intervention: Standard Tegaderm Dressing<br>Tegaderm will be applied. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |