OxyGenesys Dissolved Oxygen Dressing; Abdominoplasty at Northwestern University

Wounds Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02591537
• Other study ID #: 100-15-0001
• Status: Completed
• Phase: N/A
• First received: October 12, 2015
• Last updated: September 7, 2017
• Start date: October 2015
• Est. completion date: September 2016

Study information

• Verified date: August 2017
• Source: Halyard Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Wounds

Intervention

Device:
• OxyGenesys Dissolved Oxygen Dressing
1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing.

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Halyard Health	Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	14 days
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.	Day 14
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.	Day 14
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.	Day 28
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).	Day 42
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).	Day 42
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.	Day 42
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.	Day 42